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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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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
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

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