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Active, Not Recruiting

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 - CA209-714

Updated: 13 July, 2020   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
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Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.
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Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Nivolumab and Ipilimumab
Biological: Ipilimumab Biological: Nivolumab
Active Comparator: Nivolumab and Ipilimumab-placebo
Other: Placebo Biological: Nivolumab

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - 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) Exclusion Criteria: - 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 could apply

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
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