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 (CheckMate 714)
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| ClinicalTrials.gov Identifier: NCT02823574 |
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Recruitment Status :
Completed
First Posted : July 6, 2016
Results First Posted : April 21, 2022
Last Update Posted : April 21, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Head and Neck Cancer | Biological: Nivolumab Biological: Ipilimumab Other: Placebo | Phase 2 |
Expanded Access : An investigational treatment associated with this study has been approved for sale to the public. More info ...
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 425 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official 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) |
| Actual Study Start Date : | October 20, 2016 |
| Actual Primary Completion Date : | January 23, 2019 |
| Actual Study Completion Date : | March 11, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Nivolumab and Ipilimumab
Specified dose on specified days
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Biological: Nivolumab
Other Name: Opdivo Biological: Ipilimumab |
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Active Comparator: Nivolumab and Ipilimumab-placebo
Specified dose on specified days
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Biological: Nivolumab
Other Name: Opdivo Other: Placebo |
- 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.
- 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.
- 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.
- Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible 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.
- Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible 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.
- Progression Free Survival (PFS) 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 from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first.
- Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first.
- Overall Survival (OS) [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]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.
- Overall Survival (OS) - Platinum Refractory Subgroup [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]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.
- Overall Survival (OS) - Platinum Eligible Subgroup [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]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.
- ORR - Platinum Eligible Subgroup Based on HPV p-16 Status [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]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.
- ORR - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Biomarker [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]
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
- ORR - Platinum Refractory Subgroup Based on HPV p-16 Status [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]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.
- ORR - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Biomarker [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]
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
- Duration of Response (DOR) - Platinum Refractory Subgroup Based on HPV p-16 Status [ 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.
- Duration of Response (DOR) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status [ 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.
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
- Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on HPV p-16 Status [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first.
- Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]
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
- Overall Survival (OS) - Platinum Refractory Subgroup Based on HPV p-16 Status [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]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.
- Overall Survival (OS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]
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
- Overall Survival (OS) - Platinum Eligible Subgroup Based on HPV p-16 Status [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]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.
- Overall Survival (OS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]
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
- Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]
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
- Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on HPV p-16 Status [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first.
- Duration of Response (DOR) - Platinum Eligible Subgroup Based on HPV p-16 Status [ 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.
- Duration of Response (DOR) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status [ 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.
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
- Duration of Response (DOR) - Platinum Refractory Subgroup Based on PD-L1 Status [ 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.
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
- ORR - Platinum Refractory Subgroup Based on PD-L1 Expression [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]
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
- Overall Survival (OS) - Platinum Refractory Subgroup Based on PD-L1 Status [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]
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
- Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on PD-L1 Status [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]
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
- Duration of Response (DOR) - Platinum Eligible Subgroup Based on PD-L1 Status [ 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.
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
- ORR - Platinum Eligible Subgroup Based on PD-L1 Expression [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]
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
- Overall Survival (OS) - Platinum Eligible Subgroup Based on PD-L1 Status [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]
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
- Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on PD-L1 Status [ Time Frame: Approximately up to 30 months (from FPFV to Data base lock) ]
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02823574
Show 105 study locations
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Documents provided by Bristol-Myers Squibb:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02823574 |
| Other Study ID Numbers: |
CA209-714 2016-001645-64 ( EudraCT Number ) |
| First Posted: | July 6, 2016 Key Record Dates |
| Results First Posted: | April 21, 2022 |
| Last Update Posted: | April 21, 2022 |
| Last Verified: | March 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Head and Neck Neoplasms |
Neoplasms by Site Nivolumab Ipilimumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |