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

Completed · Phase 3

Conditions studied: Head and Neck Cancer

In brief

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

Key facts

Study ID

NCT02741570

Run by

Bristol-Myers Squibb

People needed

947

Starts

2016-10-05

Expected to finish

2022-09-22

Last updated by the study team

2023-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Local Institution - 0135 — Duarte, California, United States
• Local Institution - 0005 — Stanford, California, United States
• Local Institution - 0028 — Jacksonville, Florida, United States
• Local Institution - 0008 — Tampa, Florida, United States
• Local Institution - 0111 — Atlanta, Georgia, United States
• Local Institution - 0006 — Chicago, Illinois, United States
• Local Institution - 0001 — Boston, Massachusetts, United States
• Local Institution - 0080 — Boston, Massachusetts, United States
• Local Institution - 0093 — Boston, Massachusetts, United States
• Local Institution - 0004 — Ann Arbor, Michigan, United States
• Local Institution - 0012 — Charlotte, North Carolina, United States
• Local Institution - 0007 — Columbus, Ohio, United States
• Local Institution - 0010 — Langhorne, Pennsylvania, United States
• Local Institution - 0015 — Philadelphia, Pennsylvania, United States
• Local Institution - 0013 — Pittsburgh, Pennsylvania, United States
• Local Institution - 0139 — Dallas, Texas, United States
• Local Institution - 0009 — Houston, Texas, United States
• Local Institution - 0014 — Houston, Texas, United States
• Local Institution - 0003 — Charlottesville, Virginia, United States
• Local Institution - 0011 — Fairfax, Virginia, United States
• Local Institution - 0125 — Morgantown, West Virginia, United States
• Local Institution - 0142 — Blacktown, New South Wales, Australia
• Local Institution - 0127 — Darlinghurst, New South Wales, Australia
• Local Institution - 0128 — Gosford, New South Wales, Australia
• Local Institution - 0134 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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