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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)

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ClinicalTrials.gov Identifier: NCT02741570
Recruitment Status : Active, not recruiting
First Posted : April 18, 2016
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief 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

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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Nivolumab and Ipilimumab
Specified dose on specified days
 Biological: Nivolumab
Other Names:
  • BMS-936558
  • Opdivo

Biological: Ipilimumab
Other Names:
  • BMS-734016
  • Yervoy
Active Comparator: Extreme Regimen
Specified dose on specified days
 Drug: Cetuximab/Erbitux
Drug: Cisplatin/Platinol
Drug: Carboplatin/Paraplatin
Drug: Fluorouracil/Adrucil


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) in participants with PD-L1 expressing tumors. [ Time Frame: Approximately 51 months ]
  2. Overall Survival (OS) in all participants. [ Time Frame: Approxmiately 51 months ]

Secondary Outcome Measures :
  1. OS (overall survival) in participants with PD-LI expressing tumors with different cut off value [ Time Frame: Approximately 51 months ]
  2. ORR (objective response rate) in all participants and those with PD-L1 expressing tumors [ Time Frame: Approximately 51 months ]
  3. Duration of Response (DOR) in all participants and those with PD-L1 expressing tumors [ Time Frame: Approximately 51 months ]
  4. PFS (Progression Free Survival) in all participants and those with PD-L1 expressing tumors [ Time Frame: Approxmiately 51 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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