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
CompletedPhase 2Results postedLast updated 3 May 2023
What this trial tests
Phase 2 trial testing Nivolumab in Head and Neck Cancer in 425 participants. Completed in 21 April 2022.
18 and older, any sex, with Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory SubgroupPrimary· 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.
Group
Value
95% CI
Treatment A - Platinum Refractory Subgroup
13.2
8.4 – 19.5
Treatment B - Platinum Refractory Subgroup
18.3
10.6 – 28.4
Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory SubgroupPrimary· 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.
Group
Value
95% CI
Treatment A - Platinum Refractory Subgroup
NA
11.01 – NA
Treatment B - Platinum Refractory Subgroup
11.07
4.14 – NA
Time to Response (TTR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory SubgroupPrimary· 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.
Group
Value
95% CI
Treatment A - Platinum Refractory Subgroup
2.56
1.1 – 6.6
Treatment B - Platinum Refractory Subgroup
1.51
1.2 – 7.7
Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible SubgroupSecondary· 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.
Group
Value
95% CI
Treatment A - Platinum Eligible Subgroup
20.3
13.6 – 28.5
Treatment B - Platinum Eligible Subgroup
29.5
18.5 – 42.6
Duration of Response (DOR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible SubgroupSecondary· 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.
Group
Value
95% CI
Treatment A - Platinum Eligible Subgroup
27.04
11.01 – NA
Treatment B - Platinum Eligible Subgroup
24.61
6.90 – NA
Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory SubgroupSecondary· 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).
Group
Value
95% CI
Treatment A - Platinum Refractory Subgroup
2.50
1.45 – 2.76
Treatment B - Platinum Refractory Subgroup
2.60
1.54 – 3.38
Progression Free Survival (PFS) as Determined by Blinded Independent Central Review (BIRC) - Platinum Eligible SubgroupSecondary· 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).
Group
Value
95% CI
Treatment A - Platinum Eligible Subgroup
2.76
1.64 – 4.17
Treatment B - Platinum Eligible Subgroup
2.86
1.51 – 5.65
Overall Survival (OS)Secondary· 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.
Group
Value
95% CI
Treatment A
9.76
7.52 – 11.47
Treatment B
11.30
8.48 – 14.00
Overall Survival (OS) - Platinum Refractory SubgroupSecondary· 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.
Group
Value
95% CI
Treatment A - Platinum Refractory Subgroup
9.76
6.51 – 11.37
Treatment B - Platinum Refractory Subgroup
9.59
7.13 – 14.26
Overall Survival (OS) - Platinum Eligible SubgroupSecondary· 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.
Group
Value
95% CI
Treatment A - Platinum Eligible Subgroup
9.71
7.43 – 12.62
Treatment B - Platinum Eligible Subgroup
12.91
9.33 – 22.01
ORR - Platinum Eligible Subgroup Based on HPV p-16 StatusSecondary· 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.
Positive
Group
Value
95% CI
Treatment A - Platinum Eligible Subgroup
20.0
8.4 – 36.9
Treatment B - Platinum Eligible Subgroup
41.2
18.4 – 67.1
Negative
Group
Value
95% CI
Treatment A - Platinum Eligible Subgroup
20.5
12.6 – 30.4
Treatment B - Platinum Eligible Subgroup
25.0
13.2 – 40.3
ORR - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) BiomarkerSecondary· 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 targ
TMB < 7
Group
Value
95% CI
Treatment A - Platinum Eligible Subgroup
10.2
3.8 – 20.8
Treatment B - Platinum Eligible Subgroup
30.8
14.3 – 51.8
TMB ≥ 7
Group
Value
95% CI
Treatment A - Platinum Eligible Subgroup
34.2
19.6 – 51.4
Treatment B - Platinum Eligible Subgroup
28.6
11.3 – 52.2
TMB < 10
Group
Value
95% CI
Treatment A - Platinum Eligible Subgroup
17.3
9.8 – 27.3
Treatment B - Platinum Eligible Subgroup
28.6
14.6 – 46.3
TMB ≥ 10
Group
Value
95% CI
Treatment A - Platinum Eligible Subgroup
31.3
11.0 – 58.7
Treatment B - Platinum Eligible Subgroup
33.3
9.9 – 65.1
TMB Not Reported
Group
Value
95% CI
Treatment A - Platinum Eligible Subgroup
23.1
9.0 – 43.6
Treatment B - Platinum Eligible Subgroup
28.6
8.4 – 58.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 32 months All-Cause mortality (From randomization to end of study): Approximately 63 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment A - Platinum Refractory Subgroup
Serious: 103/158 (65%)
Deaths: 131/159
Treatment B - Platinum Refractory Subgroup
Serious: 52/82 (63%)
Deaths: 71/82
Treatment A - Platinum Eligible Subgroup
Serious: 89/122 (73%)
Deaths: 102/123
Treatment B - Platinum Eligible Subgroup
Serious: 35/61 (57%)
Deaths: 49/61
Serious adverse events (182 terms)
Reaction
System
Treatment A - Platinum Ref…
Treatment B - Platinum Ref…
Treatment A - Platinum Eli…
Treatment B - Platinum Eli…
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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)
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
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NCT07444619 — A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young A
· Phase 1
· not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease
· Phase 2
· not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma
· Phase 2
· not yet recruiting
Other recruiting trials for Head and Neck Cancer
Currently open trials in the same condition.
NCT07318220 — Prehabilitation Protocol for Head and Neck Cancer Patients
· NA
· recruiting
NCT07524114 — Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception
· recruiting
NCT07467083 — Development and Application of a Nurse-Led Preemptive Symptom Management Protocol for Head and Neck Cancer Patients Unde
· Phase 3
· recruiting
NCT07209189 — Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-esca
· Phase 2
· recruiting
NCT06837480 — Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema
· NA
· recruiting
Other Bristol-Myers Squibb trials
Trials by the same sponsor.
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NCT07459543 — A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unre
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NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder
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NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism
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NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 3 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02823574.