ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Study 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02741570
Recruitment Status : Recruiting
First Posted : April 18, 2016
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The main purpose of this study is to compare nivolumab and ipilimumab with the extreme study 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 930 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 : August 4, 2016
Estimated Primary Completion Date : August 14, 2020
Estimated Study Completion Date : August 15, 2025

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Overall Survival (OS) in participants with PD-L1 expressing tumors [ Time Frame: Approximately 46 months ]
  2. Progression Free Survival (PFS) in pariticipants with PD-L1 expressing tumors [ Time Frame: Approximately 32 months ]

Secondary Outcome Measures :
  1. OS in all participants [ Time Frame: Approximately 32 months ]
  2. PFS in all pariticipants [ Time Frame: Approximately 32 months ]
  3. Objective Response Rate (ORR) in all participants [ Time Frame: Approximately 32 months ]
  4. Duration of Response (DOR) in all participants [ Time Frame: Approximately 32 months ]


Information from the National Library of Medicine

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
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.
  • Patients 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


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


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 136 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02741570     History of Changes
Other Study ID Numbers: CA209-651
2016-000725-39 ( EudraCT Number )
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Nivolumab
Cisplatin
Carboplatin
Cetuximab
Fluorouracil
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents