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Completed

NCT Number: NCT02599402

Nivolumab Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Treatment for Patients With Advanced Melanoma

The purpose of this study is to determine the effects of combination treatment of Nivolumab with Ipilimumab followed by Nivolumab monotherapy in patients with previously untreated advanced Melanoma.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Garran, Australian Capital Territory, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

  • Potential subjects must have advanced Melanoma (stage III or IV as confirmed by biopsy) with spread to other sites in the body and unable to be removed by surgery.
  • Potential subjects must be newly diagnosed with advanced melanoma and received no treatment for the advanced disease.

NOTE: Prior adjuvant or neoadjuvant melanoma therapy (including anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways, such as anti-CD-137) is permitted if the therapy was used in the adjuvant or neoadjuvant setting but not in the metastatic setting. These drugs must be discontinued 6 months prior to study entry and the side effects related to the prior therapy resolved.

  • Potential subjects (with disease spread to brain) who previously received primary treatment are permitted if there was no evidence of disease as confirmed by the MRI (at least 2 weeks after the primary treatment is complete and with in 6 weeks of the first dose of the study drug). Potential subjects must not have received intravenous steroid treatment (>10 mg/day) intravenously for at least 2 weeks prior to study drug administration.

Exclusion criteria

  • Leptomenigeal metastases
  • Subjects with autoimmune disease. Subjects with Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • All side effects from previous primary treatments other than alopecia, fatigue, or peripheral neuropathy must have resolved to Grade 1 or baseline before administration of study drug.

Treatment and study plan

Nivolumab

Drug

Ipilimumab

Drug

Primary outcomes

  1. Incidence of Participants With High-Grade (CTCAE v4.0 Grade 3-5) Treatment-Related Select Adverse Events

    Time frame: From first dose to 30 days after last dose (up to approximately 37 months)

    Incidence of participants with high-grade (CTCAE v4.0 grade 3-5) treatment-related, select adverse events of potentially immune-mediated etiology including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity

Secondary outcomes

  1. Incidence of Participants With All High-Grade (Grades 3-5) Select Adverse Events

    Time frame: From first dose to 30 days after last dose (up to approximately 37 months)

    Incidence of participants with high-grade (grade 3-5) select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, infusion-related, or hypersensitivity

  2. Median Time to Onset (Grades 3-4) of Select Adverse Events

    Time frame: From first dose to 30 days after last dose (up to approximately 37 months)

    Median time to onset (grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity

  3. Median Time to Resolution (Grades 3-4) of Select Adverse Events

    Time frame: From first dose to 30 days after last dose (up to approximately 37 months)

    Median time to resolution (Grades 3-4) of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity

  4. Time to Resolution of an Adverse Event (AE)

    Time frame: From first dose to 30 days after last dose (up to approximately 37 months)

    Resolution of an adverse event (AE) is defined as a participant experiencing complete resolution or improvement to the baseline of any grade AE including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity

  5. Overall Survival (OS)

    Time frame: Up to approximately 37 months

    Overall survival is defined from the time of first dosing date to the date of death. A participant who has not died will be censored at the last known date alive

  6. Incidence of Participants With Adverse Events

    Time frame: From first dose to 30 days after last dose (up to approximately 37 months)

    The assessment of safety is measured by the incidence of participants who experienced any grade of adverse events (AEs), treatment-related AEs, serious adverse events (SAEs), and deaths

  7. Incidence of Participants With Select Adverse Events

    Time frame: From first dose to 30 days after last dose (up to approximately 37 months)

    The assessment of safety is measured by the incidence of participants who experienced any grade of select adverse events including pulmonary, gastrointestinal, skin, renal, hepatic, endocrine, infusion-related, or hypersensitivity

  8. Incidence of Participants With Laboratory Abnormalities - Liver

    Time frame: From first dose to 30 days after last dose (up to approximately 37 months)

    Safety assessment is measured by the incidence of participants who experienced a liver laboratory abnormality in Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Upper Limit of Normal (ULN)

  9. Incidence of Participants With Laboratory Abnormalities - Thyroid

    Time frame: From first dose to 30 days after last dose (up to approximately 37 months)

    Safety assessment is measured by the incidence of participants who experienced a thyroid laboratory abnormality in Free T3 (FT3), Free T4 (FT4), Lower Limit of Normal (LLN)

  10. Objective Response Rate (ORR)

    Time frame: Up to approximately 37 months

    Objective response rate is defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of all treated participants

  11. Progression Free Survival (PFS)

    Time frame: Up to approximately 37 months

    Progression free survival per investigator assessment is defined as radiological evidence of progression, significant clinical symptomatic progression, or the need to introduce a non-study drug therapy.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Clinical Trial of Nivolumab (BMS-936558) Combined With Ipilimumab Followed by Nivolumab Monotherapy as First-Line Therapy of Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma CheckMate 401: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 401

Acronym: CheckMate 401

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Nov 6, 2015
Registry last updated
Jun 15, 2021

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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