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Active, Not 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: 31 January, 2019   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
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.

Trial Details

  • Phase 3


  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

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

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

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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