Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
CompletedPhase 3Results postedLast updated 21 September 2023
What this trial tests
Phase 3 trial testing Nivolumab in Head and Neck Cancer in 947 participants. Completed in 22 September 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.
Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20Primary· From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)
Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)
Group
Value
95% CI
Nivolumab + Ipilimumab
17.58
13.77 – 21.98
EXTREME Regimen
14.59
12.32 – 15.97
Overall Survival (OS) in All Randomized ParticipantsPrimary· From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)
Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)
Group
Value
95% CI
Nivolumab + Ipilimumab
13.90
12.12 – 15.77
EXTREME Regimen
13.50
12.55 – 15.21
Overall Survival (OS) in Randomized Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥ 1Secondary· From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months)
Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)
Group
Value
95% CI
Nivolumab + Ipilimumab
15.67
13.70 – 18.79
EXTREME Regimen
13.24
11.07 – 14.59
Progression Free Survival (PFS)Secondary· From randomization to disease progression or death (Up to approximately 65 months)
PFS is defined as the time between the date of randomization and the date of first documented tumor progression, based on Blinded Independent Central Review (BICR) assessments (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria), or death due to any cause, whichever occurs first. Participants who neither progress nor die will be censored on the date of their last tumor assessment. Participants who receive subsequent anti-cancer therapy prior to documented progression, will be censored on the date of their last tumor assessment prior to subsequent therapy. (Based on Kaplan-
Randomized participants
Group
Value
95% CI
Nivolumab + Ipilimumab
3.29
2.83 – 4.17
EXTREME Regimen
6.77
5.78 – 7.00
Randomized PD-L1 CPS >= 20 participants
Group
Value
95% CI
Nivolumab + Ipilimumab
5.39
3.09 – 6.93
EXTREME Regimen
6.97
5.78 – 8.67
Objective Response Rate (ORR)Secondary· From randomization up to approximately 65 months
Objective Response Rate (ORR) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria by blinded independent central review (BICR) assessment.
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.
All randomized participants
Group
Value
95% CI
Nivolumab + Ipilimumab
24.2
20.4 – 28.3
EXTREME Regimen
37.1
32.7 – 41.6
Randomized PD-L1 CPS >= 20 participants
Group
Value
95% CI
Nivolumab + Ipilimumab
34.1
27.3 – 41.4
EXTREME Regimen
35.4
28.4 – 42.9
Duration of Objective Response (DOR)Secondary· From randomization to the first documented response (CR or PR) and progression (up to approximately 65 months)
The time between the first documented response (Complete response (CR) or partial response (PR)) and progression or death, per RECIST 1.1 by blinded independent central review (BICR) assessment. (Based on Kaplan-Meier Estimates)
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.
All randomized participants
Group
Value
95% CI
Nivolumab + Ipilimumab
16.59
9.69 – 29.40
EXTREME Regimen
5.88
5.45 – 6.97
Randomized PD-L1 CPS >= 20 participants
Group
Value
95% CI
Nivolumab + Ipilimumab
33.51
12.12 – NA
EXTREME Regimen
6.97
5.65 – 10.12
Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20 - Extended CollectionSecondary· From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months)
Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)
Group
Value
95% CI
Nivolumab + Ipilimumab
17.74
13.77 – 21.98
EXTREME Regimen
14.59
12.32 – 15.97
Overall Survival (OS) in All Randomized Participants - Extended CollectionSecondary· From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months)
Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)
Group
Value
95% CI
Nivolumab + Ipilimumab
13.90
12.12 – 15.77
EXTREME Regimen
13.50
12.48 – 15.11
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Nivolumab + Ipilimumab
Serious: 313/468 (67%)
Deaths: 388/472
EXTREME Regimen
Serious: 290/441 (66%)
Deaths: 406/475
Serious adverse events (382 terms)
Reaction
System
Nivolumab + Ipilimumab
EXTREME Regimen
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Pneumonia
Infections and infestations
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
Tumour haemorrhage
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The main purpose of this study is to compare nivolumab and ipilimumab with the extreme regimen as first line treatment in patients with recurrent or metastatic squamous cell of the head and neck cancer
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT07444619 — A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young A
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NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
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NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease
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NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma
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Currently open trials in the same condition.
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NCT07524114 — Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception
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NCT07467083 — Development and Application of a Nurse-Led Preemptive Symptom Management Protocol for Head and Neck Cancer Patients Unde
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NCT07209189 — Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-esca
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NCT06837480 — Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema
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· 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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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: 21 September 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/NCT02741570.