Phase 3
Completed N=947
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
Source: ClinicalTrials.gov NCT02741570 ↗Enrolled (actual)
947
Serious AEs
66.3%
Results posted
May 2022
Primary outcomePrimary: Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20 — 17.58; 14.59 Months — p=0.0469
◆ Published Evidence
Highly cited
159citations · ~53 / year
Nivolumab Plus Ipilimumab Versus EXTREME Regimen as First-Line Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: The Final Results of CheckMate 651.
Summary
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
Linked Publications (2)
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Nivolumab Plus Ipilimumab Versus EXTREME Regimen as First-Line Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: The Final Results of CheckMate 651.
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Are taxanes the future for head and neck cancer? Pragmatism in the immunotherapy era.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20 |
17.58; 14.59 | 0.0469 sig |
| PRIMARY Overall Survival (OS) in All Randomized Participants |
13.90; 13.50 | 0.4951 |
| SECONDARY Overall Survival (OS) in Randomized Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥ 1 |
15.67; 13.24 | — |
| SECONDARY Progression Free Survival (PFS) |
3.29; 6.77; 5.39; 6.97 | — |
| SECONDARY Objective Response Rate (ORR) |
24.2; 37.1; 34.1; 35.4 | — |
| SECONDARY Duration of Objective Response (DOR) |
16.59; 5.88; 33.51; 6.97 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed metastatic or recurrent squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx & larynx) that is not amenable to curative therapy.
- No prior systemic cancer therapy for recurrent or metastatic disease (except if chemotherapy was part of multimodal treatment completed 6 months prior to enrolment).
- Measurable disease detected by imaging exam (CT or MRI).
- Have tumor tissue for PD L1 expression testing, and for oropharyngeal cancer have results from testing of HPV p16 status.
Exclusion Criteria
- Metastatic or recurrent carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, squamous cell carcinoma originating from skin and salivary glands or non squamous histologies (eg. mucosal melanoma).
- No prior treatment with anti PD1, anti PD L1, anti CTLA 4 antibody or any other antibody or drugs targeting T cell costimulation or checkpoint pathways, or cetuximab or EGFR inhibitors in any treatment setting.
- Participants with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder.
- Inadequate hematologic, renal or hepatic function.
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT02741570) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.