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Completed

NCT Number: NCT04493203

Nivolumab Plus Axitinib in Patients With Anti-PD1 Refractory Advanced Melanoma

This is Phase II trial of nivolumab plus axitinib for patients with unresectable stage III or IV melanoma who have progressed on prior anti-PD1 therapy with or without concomitant anti-CTLA4 therapy. Patients will receive treatment with nivolumab 480 mg intravenously every 4 weeks and axitinib 5 mg twice daily by mouth. Patients may continue both agents for up to two years if they do not experience disease progression or dose-limiting toxicities.

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Key information

Conditions

Advanced Melanoma Unresectable Melanoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

About this study

This trial hypothesizes that decreasing hypoxia in the TME will re-sensitize melanoma tumors to anti-PD1 therapy. Axitinib has already been safely combined with anti-PD1 therapy and was overall well-tolerated. With nivolumab plus axitinib taken together, based on previously published work and data from our laboratories, it is hypothesized that axitinib can metabolically remodel the TME to render it more sensitive to ICB, specifically by reducing intra-tumoral hypoxia, increasing T cell infiltration, and increasing polyfunctional T cells. It will determined if treatment with nivolumab plus axitinib will prolong both progression-free and overall survival.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have unresectable (stage III) or advanced (stage IV) cutaneous or mucosal melanoma. Patients with uveal melanoma are not eligible.
  • Progressed on prior anti-PD1 therapy with or without anti-CTLA4 therapy. Patients may have progressed in the adjuvant setting if treated within the last 6 months. Prior treatment with BRAF/MEK inhibitors permitted, however, not required. Progression must be radiographic, and progression of disease will be confirmed by a radiologist. Patients must have progressed during anti-PD-1 therapy, defined as unequivocal progression on or within 3 months of the last dose of anti-PD-1 therapy if treated in the metastatic setting, or within 6 months if treated in the adjuvant setting.
  • Have measurable disease based on RECIST 1.1.
  • Patients do not have to have biopsiable disease to be eligible. However, patients with biopsiable disease must undergo biopsy at study entry and at week 12.
  • Have a performance status of 0 or 1 on the ECOG Performance Scale.
  • Demonstrate adequate organ function, per protocol
  • Patients with brain metastases are permitted if they are asymptomatic or previously treated with CNS directed therapy with stable CNS disease for at least 2 weeks. Stable is defined as asymptomatic or not progressing on imaging.
  • Female patients of childbearing potential - negative pregnancy testing; use of birth control, surgically sterile or abstain from heterosexual activity during study and for 5 months after the last dose of study medication.
  • Male subjects - agree to use an adequate contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy; abstinence acceptable

Exclusion criteria

  • Prior history of Grade 3 or 4 immune-related adverse events or immune-related adverse events requiring discontinuation of prior therapies.
  • History of hypertensive crisis or hypertensive encephalopathy.
  • Significant thrombotic (e.g. deep vein thrombosis or pulmonary embolism) or hemorrhagic event within 6 months prior to enrollment.
  • History of prior immune-related adverse event due to an anti-PD1 or anti-CTLA4 that has not resolved to grade 1 on a steroid dose of prednisone 10 mg or less at the time of study entry (excluding vitiligo and endocrine toxicity).
  • Patients with prior myocarditis or other immune-mediated cardiac adverse events, prior Guillain-Barre syndrome, encephalitis, meningitis, or transverse myelitis, prior Stevens-Johnson syndrome or toxic epidermal necrolysis are excluded regardless of grade.
  • Poorly controlled hypertension defined as systolic blood pressure (SBP) > 160 and/or diastolic blood pressure (DBP) > 100 despite antihypertensives. If subject is above this goal, treatment with anti-hypertensives to achieve better blood pressure control is permitted. Ambulatory blood pressure assessment is permitted if there is concern for discrepant blood pressure readings while patients are in clinic.
  • Has Class III or IV heart failure based on the New York Heart Association.
  • Has had major surgery within 4 weeks of randomization. This does not include outpatient surgeries that do not require post-operative admission.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (greater than the equivalent of prednisone 10 mg daily, unless for prior endocrine toxicity) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment (premedication with steroids for contrast imaging studies is permitted).
  • Has a known history of active TB (Bacillus Tuberculosis).
  • Hypersensitivity to nivolumab or axitinib, or any of their excipients.
  • Has had prior chemotherapy or targeted small molecule therapy within 1 week prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  • Has had radiation within 2 weeks of randomization.
  • Has current use or anticipated need for treatment with drugs or foods that are known strong cytochrome P450 (CYP34A4/5) inhibitors including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, and grapefruit or grapefruit juice. NOTE: The topical use of these medications, such as 2% ketoconazole cream is allowed.
  • Has current use or anticipated need for treatment with drugs known to be strong CYP3A4/5 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's wort.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, in situ cervical cancer, in situ colon cancer, or nonmetastatic prostate cancer not on systemic therapy.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 2 weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
  • Has an active infection requiring systemic IV antibiotic therapy.
  • Has had any of the following within the past 6 months
  • Myocardial infarction or unstable angina
  • Ventricular arrythmia
  • Acute decompensated heart failure
  • Cerebrovascular accident
  • Hypertensive emergency requiring ICU admission
  • Presence of a disorder that may impact absorption of axitinib, such as inability to take oral medication, requirement for IV alimentation, prior gastric resection, treatment for active peptic ulcer confirmed by endoscopy within the past 3 months, active GI bleed, malabsorption syndrome.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 5 months after the last dose of trial treatment for females and 7 months after the last dose of trial treatment for males.
  • Has a known history of HIV (HIV 1/2 antibodies) if the CD4 count is less than 350 mm3 or serum HIV viral load is < 25,000 IU/mL.
  • Has a known history of or is positive for hepatitis B (hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (hepatitis C virus [HCV] RNA [qualitative] is detected). Note: Without known history, testing only needs to be performed if there is clinical suspicion for Hepatitis B or C.
  • Is currently incarcerated or otherwise detained.
  • Has received a live vaccine within 30 days of planned start of study therapy. (intranasal iNinfluenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed)

Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.

Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.

Treatment and study plan

Nivolumab

Drug

Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of Immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer.

Other names: Opdivo, AG013736

Axitinib

Drug

Axitinib (AG013736; trade name Inlyta) is a small molecule tyrosine kinase inhibitor.Its primary mechanism of action is thought to be vascular endothelial growth factor receptor 1-3, c-KIT and PDGFR inhibition, this, in turn, enables it to inhibit angiogenesis (the formation of new blood vessels by tumours)

Other names: INLYTA

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  2. Overall Response Rate (ORR) - Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (prior Ipilimumab/Nivolumab treatment) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  3. Overall Response Rate (ORR) - no Prior Ipilimumab / Nivolumab

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (no prior Ipilimumab/Nivolumab treatment) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  4. Overall Response Rate (ORR) - Prior Lines of Therapy <=3

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (<=3 prior lines of therapy) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  5. Overall Response Rate (ORR) - Prior Lines of Therapy >3

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (>3 prior lines of therapy) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  6. Overall Response Rate (ORR) by iRECIST

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per iRECIST. (CR): disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least 30% decrease in sum of diameters of target lesions, with reference the baseline sum diameters. Can have had iUPD (one or more instances), but not iCPD, before iCR, iPR, or iSD

  7. Overall Response Rate (ORR) - Primary IO Resistance

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (with primary IO resistance) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  8. Overall Response Rate (ORR) - Secondary IO Resistance

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (with secondary IO resistance) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  9. Overall Response Rate (ORR) - Acral Histology

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (acral histology) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  10. Overall Response Rate (ORR) - Cutaneous Histology

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (with cutaneous histology) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  11. Overall Response Rate (ORR) - Mucosal Histology

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (with mucosal histology) who achieve Complete Response (CR) or Partial Response (PR) as best response by RECIST v1.1 criteria (with exact 95% CI). Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  12. Disease Control Rate (DCR)

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

  13. Disease Control Rate (DCR) - no Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

  14. Disease Control Rate (DCR) - Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

  15. Disease Control Rate (DCR) - Prior Lines of Therapy <=3

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (<=3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

  16. Disease Control Rate (DCR) - Prior Lines of Therapy >3

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (>3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

  17. Disease Control Rate (DCR) by iRECIST

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per iRECIST. (CR): disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least 30% decrease in sum of diameters of target lesions, with reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, reference the smallest sum diameters while on study. Can have had iUPD (one or more instances), but not iCPD, before iCR, iPR, or iSD

  18. Disease Control Rate (DCR) - Secondary IO Resistance

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (with secondary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

  19. Disease Control Rate (DCR) - Primary IO Resistance

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (with primary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

  20. Disease Control Rate (DCR) - Acral Histology

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (with acral histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

  21. Disease Control Rate (DCR) - Cutaneous Histology

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (with cutaneous histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

  22. Disease Control Rate (DCR) - Mucosal Histology

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (with mucosal histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

  23. Best Response

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).

  24. Best Response - no Prior Ipilimumab / Nivolumab

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).

  25. Best Response - Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).

  26. Best Response - Acral Histology

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (with acral histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).

  27. Best Response - Cutaneous Histology

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (with cutaneous histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression

  28. Best Response - Mucosal Histology

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (with mucosal histology) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression

  29. Best Response - Prior Lines of Therapy <=3

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (<=3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).

  30. Best Response - Prior Lines of Therapy >3

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (>3 prior lines of therapy) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progression).

  31. Best Response by iRECIST

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per iRECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Can have had iUPD (one or more instances), but not iCPD, before iCR, iPR, or iSD

  32. Best Response - Primary IO Resistance

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (w/ primary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progres

  33. Best Response - Secondary IO Resistance

    Time frame: Up to 12 weeks from baseline (after treatment)

    Percentage of patients (w/ secondary IO resistance) with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) or Progressive Disease (PD). Per RECIST v1.1. (CR): the disappearance of a target lesion. Any pathological lymph nodes (target or non-target) must have reduction in short axis to <10 mm. (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. (PD): at least a 20% increase in the sum of diameters of target lesions, taking as a reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (the appearance of one or more new lesions is also considered progres

Secondary outcomes

  1. Overall Survival (OS) - Overall Cohort

    Time frame: Up to 45 months

    The median number of months from the start of treatment that patients remain alive, until death from any cause.

  2. 6-month Overall Survival (OS)

    Time frame: Up to12 months

    Percentage of patients alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.

  3. 12-month Overall Survival (OS)

    Time frame: Up to 12 months

    Percentage of patients alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.

  4. 24-month Overall Survival (OS)

    Time frame: Up to 24 months

    Percentage of patients alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.

  5. Overall Survival (OS) - Prior Ipilimumab/Nivolumab Treatment

    Time frame: Up to 45 months

    The median number of months from the start of treatment that patients (who received prior Ipilimumab/Nivolumab treatment) remained alive, until death from any cause.

  6. 6-month Overall Survival (OS) - Prior Ipilimumab /Nivolumab Treatment

    Time frame: Up to 6 months

    Percentage of patients (previously treated with Ipilimumab/Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.

  7. 12-month Overall Survival (OS) - Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 12 months

    Percentage of patients (previously treated with Ipilimumab/Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.

  8. 24-month Overall Survival (OS) - Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 24 months

    Percentage of patients (previously treated with Ipilimumab/Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.

  9. Overall Survival (OS) - no Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 45 months

    The median number of months from the start of treatment that patients (who did not receive prior Ipilimumab /Nivolumab treatment) remained alive, until death from any cause.

  10. 6-month Overall Survival (OS) - no Prior Ipilimumab /Nivolumab Treatment

    Time frame: Up to 6 months

    Percentage of patients (not previously treated with Ipilimumab /Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.

  11. 12-month Overall Survival (OS) - no Prior Ipilimumab /Nivolumab Treatment

    Time frame: Up to 12 months

    Percentage of patients (not previously treated with Ipilimumab /Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.

  12. 24-month Overall Survival (OS) - no Prior Ipilimumab /Nivolumab Treatment

    Time frame: Up to 24 months

    Percentage of patients (not previously treated with Ipilimumab/Nivolumab), alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.

  13. Overall Survival (OS) - Acral Histology

    Time frame: Up to 45 months

    The median number of months from the start of treatment that patients (with acral histology) remain alive, until death from any cause in patients with acral melanoma histology.

  14. 6-month Overall Survival (OS) - Acral Histology

    Time frame: Up to 6 months

    Percentage of patients with acral melanoma histology that remain alive up to 6 months from start of treatment until death from any cause.

  15. 12-month Overall Survival (OS) - Acral Histology

    Time frame: Up to 12 months

    Percentage of patients with acral melanoma histology that remain alive up to 12 months from start of treatment until death from any cause.

  16. 24-month Overall Survival (OS) - Acral Histology

    Time frame: Up to 24 months

    Percentage of patients with acral melanoma histology that remain alive up to 24 months from start of treatment until death from any cause.

  17. Overall Survival (OS) - Mucosal Histology

    Time frame: Up to 45 months

    The median number of months from the start of treatment that patients remain alive, until death from any cause in patients with mucosal histology.

  18. 6-month Overall Survival (OS) - Mucosal Histology

    Time frame: Up to 6 months

    Percentage of patients with mucosal melanoma histology that remain alive up to 6 months from start of treatment until death from any cause.

  19. 12-month Overall Survival (OS) - Mucosal Histology

    Time frame: Up to 12 months

    Percentage of patients with mucosal melanoma histology that remain alive up to 12 months from start of treatment until death from any cause.

  20. 24-month Overall Survival (OS) - Mucosal Histology

    Time frame: Up to 24 months

    Percentage of patients with mucosal melanoma histology that remain alive up to 24 months from start of treatment until death from any cause.

  21. Overall Survival (OS) - Cutaneous Histology

    Time frame: Up to 45 months

    The median number of months from the start of treatment that patients remain alive, until death from any cause in patients with cutaneous melanoma histology.

  22. 6-month Overall Survival (OS) - Cutaneous Histology

    Time frame: Up to 6 months

    Percentage of patients with cutaneous melanoma histology that remain alive up to 6 months from start of treatment until death from any cause.

  23. 12-month Overall Survival (OS) - Cutaneous Histology

    Time frame: Up to 12 months

    Percentage of patients with cutaneous melanoma histology that remain alive up to 12 months from start of treatment until death from any cause.

  24. 24-month Overall Survival (OS) - Cutaneous Histology

    Time frame: Up to 24 months

    Percentage of patients with cutaneous melanoma histology that remain alive up to 24 months from start of treatment until death from any cause.

  25. Overall Survival (OS) - Prior Lines of Therapy >3

    Time frame: Up to 45 months

    The median number of months from the start of treatment that patients with greater than 3 prior lines of treatment remain alive, until death from any cause.

  26. 6-month Overall Survival (OS) - Prior Lines of Therapy >3

    Time frame: Up to 6 months

    Percentage of patients (who received > 3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.

  27. 12-month Overall Survival (OS) - Prior Lines of Therapy >3

    Time frame: Up to 12 months

    Percentage of patients (who received > 3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.

  28. 24-month Overall Survival (OS) - Prior Lines of Therapy >3

    Time frame: Up to 24 months

    Percentage of patients (who received > 3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.

  29. Overall Survival (OS) - Prior Lines of Therapy <=3

    Time frame: Up to 45 months

    The median number of months from the start of treatment that patients who received 3 or less prior lines of treatment remain alive, until death from any cause.

  30. 6-month Overall Survival (OS) - Prior Lines of Therapy <=3

    Time frame: Up to 6 months

    Percentage of patients (who received <=3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.

  31. 12-month Overall Survival (OS) - Prior Lines of Therapy <=3

    Time frame: Up to 12 months

    Percentage of patients (who received <=3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.

  32. 24-month Overall Survival (OS) - Prior Lines of Therapy <=3

    Time frame: Up to 24 months

    Percentage of patients (who received <=3 prior lines therapy) alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.

  33. Overall Survival (OS) - Overall Cohort - Primary IO Resistance

    Time frame: Up to 45 months

    The median number of months from the start of treatment that patients with Primary IO resistance remain alive, until death from any cause.

  34. 6-month Overall Survival (OS) - Primary IO Resistance

    Time frame: Up to 6 months

    Percentage of patients (Primary IO resistance) alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.

  35. 12-month Overall Survival (OS) - Primary IO Resistance

    Time frame: Up to 12 months

    Percentage of patients (Primary IO resistance) alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.

  36. 24-month Overall Survival (OS) - Primary IO Resistance

    Time frame: Up to 24 months

    Percentage of patients (Primary IO resistance) alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.

  37. Overall Survival (OS) - Overall Cohort - Secondary IO Resistance

    Time frame: Up to 45 months

    The median number of months from the start of treatment that patients with Secondary IO resistance remain alive, until death from any cause.

  38. 6-month Overall Survival (OS) - Secondary IO Resistance

    Time frame: Up to 6 months

    Percentage of patients with Secondary IO resistance alive from the start of treatment that patients remain alive, until death from any cause up to 6 months.

  39. 12-month Overall Survival (OS) - Secondary IO Resistance

    Time frame: Up to 12 months

    Percentage of patients with Secondary IO resistance alive from the start of treatment that patients remain alive, until death from any cause up to 12 months.

  40. 24-month Overall Survival (OS) - Secondary IO Resistance

    Time frame: Up to 24 months

    Percentage of patients with Secondary IO resistance alive from the start of treatment that patients remain alive, until death from any cause up to 24 months.

  41. Progression-free Survival (PFS) - Overall Cohort

    Time frame: Up to 4 years and 3 months

    The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  42. 6-month Progression-free Survival (PFS)

    Time frame: Up to 6 months

    The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  43. 12-month Progression-free Survival (PFS)

    Time frame: Up to 12 months

    The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  44. 24-month Progression-free Survival (PFS)

    Time frame: Up to 24 months

    The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  45. Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 4 years and 3 months

    The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  46. 6-month Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 6 months

    The percentage of patients (previously treated with Ipilimumab/Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  47. 12-month Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 12 months

    The percentage of patients (previously treated with Ipilimumab / Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  48. 24-month Progression-free Survival (PFS) - Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 24 months

    The percentage of patients (previously treated with Ipilimumab/Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  49. Progression-free Survival (PFS) - no Prior Ipilimumab /Nivolumab Treatment

    Time frame: Up to 4 years and 3 months

    The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  50. 6-month Progression-free Survival (PFS) - no Prior Ipilimumab/Nivolumab Treatment

    Time frame: Up to 6 months

    The percentage of patients (not previously treated with Ipilimumab /Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  51. 12-month Progression-free Survival (PFS) - no Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 12 months

    The percentage of patients (not previously treated with Ipilimumab /Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  52. 24-month Progression-free Survival (PFS) - no Prior Ipilimumab /Nivolumab Treatment

    Time frame: Up to 24 months

    The percentage of patients (not previously treated with Ipilimumab /Nivolumab) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  53. Progression-free Survival (PFS) - Overall Cohort - Mucosal Histology

    Time frame: Up to 4 years and 3 months

    The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  54. 6-month Progression-free Survival (PFS) - Mucosal Histology

    Time frame: Up to 6 months

    The percentage of patients (with mucosal histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  55. 12-month Progression-free Survival (PFS) - Mucosal Histology

    Time frame: Up to 12 months

    The percentage of patients (with mucosal histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  56. 24-month Progression-free Survival (PFS) - Mucosal Histology

    Time frame: Up to 24 months

    The percentage of patients (with mucosal histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  57. Progression-free Survival (PFS) - Overall Cohort - Cutaneous Histology

    Time frame: Up to 4 years and 3 months

    The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  58. 6-month Progression-free Survival (PFS) - Cutaneous Histology

    Time frame: Up to 6 months

    The percentage of patients (with cutaneous histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  59. 12-month Progression-free Survival (PFS) - Cutaneous Histology

    Time frame: Up to 12 months

    The percentage of patients (with cutaneous histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  60. 24-month Progression-free Survival (PFS) - Cutaneous Histology

    Time frame: Up to 24 months

    The percentage of patients (with cutaneous histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  61. Progression-free Survival (PFS) - Overall Cohort - Acral Histology

    Time frame: Up to 4 years and 3 months

    The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  62. 6-month Progression-free Survival (PFS) - Acral Histology

    Time frame: Up to 6 months

    The percentage of patients (with acral histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  63. 12-month Progression-free Survival (PFS) - Acral Histology

    Time frame: Up to 12 months

    The percentage of patients (with acral histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  64. 24-month Progression-free Survival (PFS) - Acral Histology

    Time frame: Up to 24 months

    The percentage of patients (with acral histology) who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  65. Progression-free Survival (PFS) - Overall Cohort - Prior Lines <= 3

    Time frame: Up to 4 years and 3 months

    The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  66. 6-month Progression-free Survival (PFS) - Prior Lines <= 3

    Time frame: Up to 6 months

    The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  67. 12-month Progression-free Survival (PFS) - Prior Lines <= 3

    Time frame: Up to 12 months

    The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  68. 24-month Progression-free Survival (PFS) - Prior Lines <= 3

    Time frame: Up to 24 months

    The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  69. Progression-free Survival (PFS) - Overall Cohort - Prior Lines >3

    Time frame: Up to 4 years and 3 months

    The median time measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression), whichever occurs first, with progression defined by RECIST v 1.1. in patients with mucosal histology. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  70. 6-month Progression-free Survival (PFS) - Prior Lines > 3

    Time frame: Up to 6 months

    The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 6 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  71. 12-month Progression-free Survival (PFS) - Prior Lines > 3

    Time frame: Up to 12 months

    The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 12 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  72. 24-month Progression-free Survival (PFS) - Prior Lines > 3

    Time frame: Up to 24 months

    The percentage of patients who do not experience documented progression, or death (in the absence of progression), whichever occurs first, within 24 months start of treatment. Per RECIST v 1.1. Progressive disease (PD) is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  73. Duration of Response (DoR) - Overall Cohort

    Time frame: Up to 4 years and 3 months

    Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  74. 6-month Duration of Response (DoR) - Overall Cohort

    Time frame: Up to 6 months

    Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  75. 12-month Duration of Response (DoR) - Overall Cohort

    Time frame: Up to 12 months

    Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  76. 24-month Duration of Response (DoR) - Overall Cohort

    Time frame: Up to 24 months

    Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  77. Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 4 years and 3 months

    Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  78. 6-month Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 6 months

    Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  79. 12-month Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 12 months

    Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  80. 24-month Duration of Response (DoR) - Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 24 months

    Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  81. Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 4 years and 3 months

    Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  82. 6-month Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 6 months

    Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  83. 12-month Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 12 months

    Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  84. 24-month Duration of Response (DoR) - no Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 24 months

    Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  85. Duration of Response (DoR) - Acral Histology

    Time frame: Up to 4 years and 3 months

    Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  86. 6-month Duration of Response (DoR) - Acral Histology

    Time frame: Up to 6 months

    Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  87. 12-month Duration of Response (DoR) - Acral Histology

    Time frame: Up to 12 months

    Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  88. 24-month Duration of Response (DoR) - Acral Histology

    Time frame: Up to 24 months

    Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  89. Duration of Response (DoR) - Mucosal Histology

    Time frame: Up to 4 years and 3 months

    Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  90. 6-month Duration of Response (DoR) - Mucosal Histology

    Time frame: Up to 6 months

    Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  91. 12-month Duration of Response (DoR) - Mucosal Histology

    Time frame: Up to 12 months

    Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  92. 24-month Duration of Response (DoR) - Mucosal Histology

    Time frame: Up to 24 months

    Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  93. Duration of Response (DoR) - Cutaneous Histology

    Time frame: Up to 4 years and 3 months

    Median number of months from the first confirmed response (CR/PR) to date of the first progression or death from any cause. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  94. 6-month Duration of Response (DoR) - Cutaneous Histology

    Time frame: Up to 6 months

    Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 6 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  95. 12-month Duration of Response (DoR) - Cutaneous Histology

    Time frame: Up to 12 months

    Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 12 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  96. 24-month Duration of Response (DoR) - Cutaneous Histology

    Time frame: Up to 24 months

    Percentage of patients whose Complete Response (CR) or Partial Response (PR) remains as such at 24 months from date of first confirmed response. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR) is defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.

  97. Duration of Disease Control (DoDC) - Overall Cohort

    Time frame: Up to 4 years and 3 months

    Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  98. 6-month Duration of Disease Control (DoDC) - Overall Cohort

    Time frame: Up to 6 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  99. 12-month Duration of Disease Control (DoDC) - Overall Cohort

    Time frame: Up to 12 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  100. 24-month Duration of Disease Control (DoDC) - Overall Cohort

    Time frame: Up to 24 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  101. Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 4 years and 3 months

    Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  102. 6-month Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 6 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  103. 12-month Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 12 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  104. 24-month Duration of Disease Control (DoDC) - Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 24 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  105. Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 4 years and 3 months

    Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  106. 6-month Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 6 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  107. 12-month Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 12 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  108. 24-month Duration of Disease Control (DoDC) - no Prior Ipilimumab / Nivolumab Treatment

    Time frame: Up to 24 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  109. Duration of Disease Control (DoDC) - Acral Histology

    Time frame: Up to 4 years and 3 months

    Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  110. 6-month Duration of Disease Control (DoDC) - Acral Histology

    Time frame: Up to 6 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  111. 12-month Duration of Disease Control (DoDC) - Acral Histology

    Time frame: Up to 12 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  112. 24-month Duration of Disease Control (DoDC) - Acral Histology

    Time frame: Up to 24 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  113. Duration of Disease Control (DoDC) - Mucosal Histology

    Time frame: Up to 4 years and 3 months

    Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  114. 6-month Duration of Disease Control (DoDC) - Mucosal Histology

    Time frame: Up to 6 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  115. 12-month Duration of Disease Control (DoDC) - Mucosal Histology

    Time frame: Up to 12 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  116. 24-month Duration of Disease Control (DoDC) - Mucosal Histology

    Time frame: Up to 24 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  117. Duration of Disease Control (DoDC) - Cutaneous Histology

    Time frame: Up to 4 years and 3 months

    Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  118. 6-month Duration of Disease Control (DoDC) - Cutaneous Histology

    Time frame: Up to 6 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  119. 12-month Duration of Disease Control (DoDC) - Cutaneous Histology

    Time frame: Up to 12 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  120. 24-month Duration of Disease Control (DoDC) - Cutaneous Histology

    Time frame: Up to 24 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  121. Duration of Disease Control (DoDC) - Prior Lines > 3

    Time frame: Up to 4 years and 3 months

    Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  122. 6-month Duration of Disease Control (DoDC) - Prior Lines > 3

    Time frame: Up to 6 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  123. 12-month Duration of Disease Control (DoDC) - Prior Lines > 3

    Time frame: Up to 12 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  124. 24-month Duration of Disease Control (DoDC) - Prior Lines > 3

    Time frame: Up to 24 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  125. Duration of Disease Control (DoDC) - Prior Lines <= 3

    Time frame: Up to 4 years and 3 months

    Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  126. 6-month Duration of Disease Control (DoDC) - Prior Lines <= 3

    Time frame: Up to 6 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  127. 12-month Duration of Disease Control (DoDC) - Prior Lines <= 3

    Time frame: Up to 12 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  128. 24-month Duration of Disease Control (DoDC) - Prior Lines <= 3

    Time frame: Up to 24 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  129. Duration of Disease Control (DoDC) - Overall Cohort - Primary IO Resistance

    Time frame: Up to 4 years and 3 months

    Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  130. 6-month Duration of Disease Control (DoDC) - Primary IO Resistance

    Time frame: Up to 6 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  131. 12-month Duration of Disease Control (DoDC) - Primary IO Resistance

    Time frame: Up to 12 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  132. 24-month Duration of Disease Control (DoDC) - Primary IO Resistance

    Time frame: Up to 24 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  133. Duration of Disease Control (DoDC) - Overall Cohort - Secondary IO Resistance

    Time frame: Up to 4 years and 3 months

    Median number of months from the date of first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  134. 6-month Duration of Disease Control (DoDC) - Secondary IO Resistance

    Time frame: Up to 6 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  135. 12-month Duration of Disease Control (DoDC) - Secondary IO Resistance

    Time frame: Up to 12 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  136. 24-month Duration of Disease Control (DoDC) - Secondary IO Resistance

    Time frame: Up to 24 months

    Percentage of patients with first disease control (i.e. complete response [CR], partial response [PR], and stable disease [SD]) to progression [PD]. Per RECIST v1.1, (CR) = disappearance of all target lesions; disappearance of all non-target lesions and normalization of tumor marker level. (PR) = at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. (SD) = neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study. PD = at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  137. Grade 3 or Greater Adverse Events Possibly, Probably or Definitely Related to Study Treatment

    Time frame: Up to 28 days after discontinuation of study treatment (up to 24 months)

    Adverse Events determined to be possibly, probably or definitely related to study treatment SAEs are defined as grade 3 and higher toxicity events that are attributable to the study combination therapy. Evaluated by NCI Common Terminology for Adverse Events (CTCAE v5.0).

Sponsors and collaborators

Lead sponsor

Yana Najjar

Other

Collaborators

  • Bristol-Myers Squibb
  • Pfizer

Registry information

Official study title

A Phase II Trial of Nivolumab Plus Axitinib in Patients With Anti-PD1 Refractory Advanced Melanoma

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Jul 30, 2020
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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