TriangleNCT02823574 · CITED IN SOURCE DOCUMENTS
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
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2023-05-03
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)
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup
Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup
Time to Response (TTR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup
Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup
Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup
Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup
Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible Subgroup
Overall Survival (OS)
Overall Survival (OS) - Platinum Refractory Subgroup
Overall Survival (OS) - Platinum Eligible Subgroup
ORR - Platinum Eligible Subgroup Based on HPV p-16 Status
ORR - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Biomarker
ORR - Platinum Refractory Subgroup Based on HPV p-16 Status
ORR - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Biomarker
Duration of Response (DOR) - Platinum Refractory Subgroup Based on HPV p-16 Status
Duration of Response (DOR) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on HPV p-16 Status
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status
Overall Survival (OS) - Platinum Refractory Subgroup Based on HPV p-16 Status
Overall Survival (OS) - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Status
Overall Survival (OS) - Platinum Eligible Subgroup Based on HPV p-16 Status
Overall Survival (OS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on HPV p-16 Status
Duration of Response (DOR) - Platinum Eligible Subgroup Based on HPV p-16 Status
Duration of Response (DOR) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status
Duration of Response (DOR) - Platinum Refractory Subgroup Based on PD-L1 Status
ORR - Platinum Refractory Subgroup Based on PD-L1 Expression
Overall Survival (OS) - Platinum Refractory Subgroup Based on PD-L1 Status
Progression Free Survival (PFS) - Platinum Refractory Subgroup Based on PD-L1 Status
Duration of Response (DOR) - Platinum Eligible Subgroup Based on PD-L1 Status
ORR - Platinum Eligible Subgroup Based on PD-L1 Expression
Overall Survival (OS) - Platinum Eligible Subgroup Based on PD-L1 Status
Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on PD-L1 Status
Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup - Post Hoc Analysis
Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup - Post Hoc Analysis
Time to Response (TTR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup - Post Hoc Analysis
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Specified dose on specified days
- intervention Names
- Biological: Nivolumab
- Biological: Ipilimumab
- label
- Nivolumab and Ipilimumab
- type
- EXPERIMENTAL
- description
- Specified dose on specified days
- intervention Names
- Biological: Nivolumab
- Other: Placebo
- label
- Nivolumab and Ipilimumab-placebo
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Nivolumab and Ipilimumab
- Nivolumab and Ipilimumab-placebo
- name
- Nivolumab
- other Names
- Opdivo
- type
- BIOLOGICAL
- arm Group Labels
- Nivolumab and Ipilimumab
- name
- Ipilimumab
- type
- BIOLOGICAL
- arm Group Labels
- Nivolumab and Ipilimumab-placebo
- name
- Placebo
- type
- OTHER
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- DOUBLE
- who Masked
- PARTICIPANT
- INVESTIGATOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 425
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- 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)
- description
- 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.
- measure
- 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)
- description
- 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.
- measure
- 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)
- secondary Outcomes
- description
- 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.
- measure
- 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
- description
- 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.
- measure
- 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
- description
- 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).
- measure
- 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
- description
- 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).
- measure
- 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
- description
- 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.
- measure
- Overall Survival (OS)
- time Frame
- From randomization to death. Approximately 63 Months
- description
- 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.
- measure
- Overall Survival (OS) - Platinum Refractory Subgroup
- time Frame
- From randomization to death. Approximately 63 Months
- description
- 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.
- measure
- Overall Survival (OS) - Platinum Eligible Subgroup
- time Frame
- From randomization to death. Approximately 63 Months
- description
- 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.
- measure
- ORR - Platinum Eligible Subgroup Based on HPV p-16 Status
- time Frame
- From randomization to end of study. Approximately 63 Months
- description
- 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.
- measure
- ORR - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Biomarker
- time Frame
- From randomization to end of study. Approximately 63 Months
- description
- 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.
- measure
- ORR - Platinum Refractory Subgroup Based on HPV p-16 Status
- time Frame
- From randomization to end of study. Approximately 63 Months
- description
- 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.
- measure
- ORR - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Biomarker
- time Frame
- From randomization to end of study. Approximately 63 Months
- description
- 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.
- measure
- 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
Full study description
- brief Summary
- 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)
Source references
- references
- citation
- Harrington KJ, Ferris RL, Gillison M, Tahara M, Argiris A, Fayette J, Schenker M, Bratland A, Walker JWT, Grell P, Even C, Chung CH, Redman R, Coutte A, Salas S, Grant C, de Azevedo S, Soulieres D, Hansen AR, Wei L, Khan TA, Miller-Moslin K, Roberts M, Haddad R. Efficacy and Safety of Nivolumab Plus Ipilimumab vs Nivolumab Alone for Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: The Phase 2 CheckMate 714 Randomized Clinical Trial. JAMA Oncol. 2023 Jun 1;9(6):779-789. doi: 10.1001/jamaoncol.2023.0147.
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- BMS Clinical Trial Patient Recruiting
- label
- FDA Safety Alerts and Recalls
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice