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Recruiting

Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Patients With Cisplatin-ineligible or Eligible Locally Advanced Squamous Cell Head and Neck Cancer - CA209-9TM

Updated: 08 October, 2018   |   ClinicalTrials.gov

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participants 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.

Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 46

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Arm A
Radiation: Radiotherapy Drug: Cetuximab Placebo Biological: Nivolumab
Experimental: Arm B
Radiation: Radiotherapy Drug: Nivolumab Placebo Drug: Cetuximab
Experimental: Arm C
Biological: Nivolumab Drug: Cisplatin Radiation: Radiotherapy
Experimental: Arm D
Drug: Nivolumab Placebo Drug: Cisplatin Radiation: Radiotherapy

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Histologically proven squamous cell carcinoma of the head and neck (SCCHN) from one of the following primary sites: oral cavity, oropharynx, hypopharynx, and larynx - Locally advanced disease which is unresectable, or resectable but suitable for an organ sparing approach - No previous radiotherapy or systemic treatment for SCCHN Exclusion Criteria: - Carcinoma originating in the nasopharynx or paranasal sinus, squamous cell carcinoma that originated from the skin and salivary gland or non-squamous histology (e.g., mucosal melanoma), squamous cell carcinoma of unknown primary - Clinical or radiological evidence of metastatic disease - Prior radiotherapy that overlaps with radiation fields Other protocol defined inclusion/exclusion criteria could apply

Have questions? Call 855-907-3286 or Email Us

Have questions?
Call 855-907-3286 or Email Us