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 (CheckMate 651)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02741570 |
Recruitment Status :
Active, not recruiting
First Posted : April 18, 2016
Last Update Posted : February 1, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Head and Neck Cancer | Biological: Nivolumab Biological: Ipilimumab Drug: Cetuximab/Erbitux Drug: Cisplatin/Platinol Drug: Carboplatin/Paraplatin Drug: Fluorouracil/Adrucil | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 947 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open Label, Randomized, Two Arm Phase III Study of Nivolumab in Combination With Ipilimumab Versus Extreme Study Regimen (Cetuximab + Cisplatin/Carboplatin + Fluorouracil) as First Line Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) |
Actual Study Start Date : | October 5, 2016 |
Estimated Primary Completion Date : | April 14, 2021 |
Estimated Study Completion Date : | February 4, 2026 |

Arm | Intervention/treatment |
---|---|
Experimental: Nivolumab and Ipilimumab
Specified dose on specified days
|
Biological: Nivolumab
Other Names:
Biological: Ipilimumab Other Names:
|
Active Comparator: Extreme Regimen
Specified dose on specified days
|
Drug: Cetuximab/Erbitux Drug: Cisplatin/Platinol Drug: Carboplatin/Paraplatin Drug: Fluorouracil/Adrucil |
- Overall Survival (OS) in participants with PD-L1 expressing tumors. [ Time Frame: Approximately 51 months ]
- Overall Survival (OS) in all participants. [ Time Frame: Approxmiately 51 months ]
- OS (overall survival) in participants with PD-LI expressing tumors with different cut off value [ Time Frame: Approximately 51 months ]
- ORR (objective response rate) in all participants and those with PD-L1 expressing tumors [ Time Frame: Approximately 51 months ]
- Duration of Response (DOR) in all participants and those with PD-L1 expressing tumors [ Time Frame: Approximately 51 months ]
- PFS (Progression Free Survival) in all participants and those with PD-L1 expressing tumors [ Time Frame: Approxmiately 51 months ]

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 |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
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

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): NCT02741570

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT02741570 |
Other Study ID Numbers: |
CA209-651 2016-000725-39 ( EudraCT Number ) |
First Posted: | April 18, 2016 Key Record Dates |
Last Update Posted: | February 1, 2021 |
Last Verified: | January 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
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 Cisplatin Carboplatin Fluorouracil |
Nivolumab Cetuximab Ipilimumab Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Immunological |