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Completed

NCT Number: NCT02823574

Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution - 0121, Pergamino, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed squamous cell head and neck cancer
  • Widespread (metastatic) disease, or returned after previous treatment (recurrent)
  • Tumor sample must be available for analysis of PDL1 (Programmed death-ligand 1) and HPV [Human Papilloma Virus (oropharynx only)]
  • Performance status ECOG 0-1 (Eastern Cooperative Oncology Group)

Exclusion criteria

  • Previous treatment for metastatic or recurrent disease
  • Cancer arising from one of the following primary sites: paranasal sinus, nasopharynx, salivary gland, skin
  • Any non-squamous subtype
  • Active autoimmune disease
  • Positive test for hepatitis B, C or HIV (Human Immunodeficiency Virus) virus
  • Previous treatment with checkpoint inhibitor drugs
  • Active CNS metastases or carcinomatous meningitis

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

Nivolumab

Biological

Other names: Opdivo

Ipilimumab

Biological

Placebo

Other

Primary outcomes

  1. Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup

    Time frame: Approximately up to 30 months (from FPFV to Data base lock)

    ORR is defined as best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group.

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  2. Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup

    Time frame: Approximately up to 30 months (from FPFV to Data base lock)

    The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

  3. Time to Response (TTR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup

    Time frame: Approximately up to 30 months (from FPFV to Data base lock)

    Time to Response (TTR) for participants demonstrating a response (either CR or PR) was defined as the time from the date of randomization to the date of the first confirmed response.

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Secondary outcomes

  1. Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup

    Time frame: From randomization to end of study. Approximately 63 Months

    ORR is defined as percentage of participants with a complete response (CR) or partial response (PR).

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  2. Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup

    Time frame: From randomization to disease progression or death. Approximately 63 Months

    The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

  3. Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup

    Time frame: From randomization to disease progression or death. Approximately 63 Months

    The time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first.

    Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as 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. (Note: the appearance of one or more new lesions is also considered progression).

  4. Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup

    Time frame: From randomization to disease progression or death. Approximately 63 Months

    the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first.

    Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as 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. (Note: the appearance of one or more new lesions is also considered progression).

  5. Overall Survival (OS)

    Time frame: From randomization to death. Approximately 63 Months

    Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up.

  6. Overall Survival (OS) - Platinum Refractory Subgroup

    Time frame: From randomization to death. Approximately 63 Months

    Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up.

  7. Overall Survival (OS) - Platinum Eligible Subgroup

    Time frame: From randomization to death. Approximately 63 Months

    Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up.

  8. ORR - Platinum Eligible Subgroup Based on HPV p-16 Status

    Time frame: From randomization to end of study. Approximately 63 Months

    ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group.

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  9. ORR - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Biomarker

    Time frame: From randomization to end of study. Approximately 63 Months

    ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group.

    Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  10. ORR - Platinum Refractory Subgroup Based on HPV p-16 Status

    Time frame: From randomization to end of study. Approximately 63 Months

    ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group.

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  11. ORR - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Biomarker

    Time frame: From randomization to end of study. Approximately 63 Months

    ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group.

    Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  12. Duration of Response (DOR) - Platinum Refractory Subgroup Based on HPV p-16 Status

    Time frame: From randomization to disease progression or death. Approximately 63 Months

    The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

  13. Duration of Response (DOR) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status

    Time frame: From randomization to disease progression or death. Approximately 63 Months

    The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

    Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb

  14. Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on HPV p-16 Status

    Time frame: From randomization to disease progression or death. Approximately 63 Months

    the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first.

    Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as 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. (Note: the appearance of one or more new lesions is also considered progression).

  15. Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status

    Time frame: From randomization to disease progression or death. Approximately 63 Months

    the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first.

    Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb

    Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as 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. (Note: the appearance of one or more new lesions is also considered progression).

  16. Overall Survival (OS) - Platinum Refractory Subgroup Based on HPV p-16 Status

    Time frame: From randomization to death. Approximately 63 Months

    Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up.

  17. Overall Survival (OS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status

    Time frame: From randomization to death. Approximately 63 Months

    Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up.

    Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb

  18. Overall Survival (OS) - Platinum Eligible Subgroup Based on HPV p-16 Status

    Time frame: From randomization to death. Approximately 63 Months

    Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up.

  19. Overall Survival (OS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status

    Time frame: From randomization to death. Approximately 63 Months

    Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up.

    Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb

  20. Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status

    Time frame: From randomization to disease progression or death. Approximately 63 Months

    the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first.

    Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb

    Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as 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. (Note: the appearance of one or more new lesions is also considered progression).

  21. Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on HPV p-16 Status

    Time frame: From randomization to disease progression or death. Approximately 63 Months

    the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first.

    Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as 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. (Note: the appearance of one or more new lesions is also considered progression).

  22. Duration of Response (DOR) - Platinum Eligible Subgroup Based on HPV p-16 Status

    Time frame: From randomization to disease progression or death. Approximately 63 Months

    The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

    Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as 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. (Note: the appearance of one or more new lesions is also considered progression).

  23. Duration of Response (DOR) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status

    Time frame: From randomization to disease progression or death. Approximately 63 Months

    The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

    Tumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb.

    Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as 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. (Note: the appearance of one or more new lesions is also considered progression).

  24. Duration of Response (DOR) - Platinum Refractory Subgroup Based on PD-L1 Status

    Time frame: From randomization to disease progression or death. Approximately 63 Months

    The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

    Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay.

    Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as 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. (Note: the appearance of one or more new lesions is also considered progression).

  25. ORR - Platinum Refractory Subgroup Based on PD-L1 Expression

    Time frame: From randomization to end of study. Approximately 63 Months

    ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group.

    Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay

    Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  26. Overall Survival (OS) - Platinum Refractory Subgroup Based on PD-L1 Status

    Time frame: From randomization to death. Approximately 63 Months

    Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up.

    Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay

  27. Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on PD-L1 Status

    Time frame: From randomization to disease progression or death. Approximately 63 Months

    The time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first.

    Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay.

    Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as 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. (Note: the appearance of one or more new lesions is also considered progression).

  28. Duration of Response (DOR) - Platinum Eligible Subgroup Based on PD-L1 Status

    Time frame: From randomization to disease progression or death. Approximately 63 Months

    The time between the date of first confirmed response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first.

    Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay

    Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as 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. (Note: the appearance of one or more new lesions is also considered progression).

  29. ORR - Platinum Eligible Subgroup Based on PD-L1 Expression

    Time frame: From randomization to end of study. Approximately 63 Months

    ORR is defined as the best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group.

    Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to < 10 mm.

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  30. Overall Survival (OS) - Platinum Eligible Subgroup Based on PD-L1 Status

    Time frame: From randomization to death. Approximately 63 Months

    Overall survival was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up.

    Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay

  31. Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on PD-L1 Status

    Time frame: From randomization to disease progression or death. Approximately 63 Months

    The time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first.

    Tumor PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay

    Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as 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. (Note: the appearance of one or more new lesions is also considered progression).

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Double-Blind, Randomized, Two Arm Phase 2 Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Acronym: CheckMate 714

Important dates

Study start
2016
Primary completion
2019
Study completion
2022
First posted
Jul 6, 2016
Registry last updated
May 3, 2023

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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