Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Completed · Phase 2 · Has a placebo group

Conditions studied: Head and Neck Cancer

In brief

A study in patients with metastatic or recurrent squamous cell cancer of the head and neck to evaluate the effectiveness of Nivolumab plus Ipilumumab vs. Nivolumab alone (CheckMate 714)

Key facts

Study ID

NCT02823574

Run by

Bristol-Myers Squibb

People needed

425

Starts

2016-11-08

Expected to finish

2022-04-21

Last updated by the study team

2023-05-03

Who can join

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

You may qualify if…

• Confirmed squamous cell head and neck cancer
• Widespread (metastatic) disease, or returned after previous treatment (recurrent)
• Tumor sample must be available for analysis of PDL1 (Programmed death-ligand 1) and HPV [Human Papilloma Virus (oropharynx only)]
• Performance status ECOG 0-1 (Eastern Cooperative Oncology Group)

You may not qualify if…

• Previous treatment for metastatic or recurrent disease
• Cancer arising from one of the following primary sites: paranasal sinus, nasopharynx, salivary gland, skin
• Any non-squamous subtype
• Active autoimmune disease
• Positive test for hepatitis B, C or HIV (Human Immunodeficiency Virus) virus
• Previous treatment with checkpoint inhibitor drugs
• Active CNS metastases or carcinomatous meningitis
• Other protocol-defined inclusion/exclusion criteria apply

Where it is running

• Local Institution - 0034 — Duarte, California, United States
• Los Angeles Cancer Network — Los Angeles, California, United States
• Ucla Department Of Medicine — Los Angeles, California, United States
• Local Institution - 0098 — Redondo Beach, California, United States
• Local Institution - 0004 — Sacramento, California, United States
• Local Institution - 0072 — San Francisco, California, United States
• Local Institution - 0097 — San Luis Obispo, California, United States
• Central Coast Med Oncology — Santa Maria, California, United States
• Local Institution - 0101 — New Haven, Connecticut, United States
• Local Institution - 0007 — Tampa, Florida, United States
• Local Institution - 0010 — Atlanta, Georgia, United States
• Local Institution - 0015 — Decatur, Georgia, United States
• Local Institution - 0087 — Chicago, Illinois, United States
• Ft. Wayne Med Onco-Hema Inc — Fort Wayne, Indiana, United States
• Local Institution - 0005 — Louisville, Kentucky, United States
• Oncology Associated Of Western Kentucky — Paducah, Kentucky, United States
• Local Institution - 0001 — Boston, Massachusetts, United States
• Local Institution - 0071 — Boston, Massachusetts, United States
• Local Institution - 0042 — Rochester, Minnesota, United States
• Mission Hospital, Inc — Asheville, North Carolina, United States
• Local Institution - 0103 — Cincinnati, Ohio, United States
• Local Institution - 0070 — Cleveland, Ohio, United States
• Local Institution - 0008 — Portland, Oregon, United States
• Local Institution - 0006 — Pittsburgh, Pennsylvania, United States
• University of Arizona Cancer Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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