for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion



This study has two, independent, cohorts, both in locally advanced squamous cell head and neck cancer. The purpose of the first cohort is to determine whether nivolumab in combination with radiotherapy is more effective than cetuximab in combination with radiotherapy, in subjects who are ineligible for cisplatin. The purpose of the second cohort is to determine whether nivolumab, cisplatin, and radiotherapy is more effective than cisplatin and radiotherapy in subjects who are eligible to receive cisplatin

Official Title

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Nivolumab or Nivolumab Plus Cisplatin, in Combination With Radiotherapy in Participants With Cisplatin Ineligible and Cisplatin Eligible Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)


Squamous Cell Carcinoma of the Head and Neck Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Cisplatin Nivolumab Cetuximab Radiotherapy


For people ages 18 years and up

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit

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


  • University of California San Diego (UCSD)
    La Jolla California 92093 United States
  • UCLA Health
    Los Angeles California 90095 United States


in progress, not accepting new patients
Start Date
Completion Date
Bristol-Myers Squibb
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Phase 3
Study Type
Last Updated