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

• Status: Completed
• Trial end date: 2019-10-14
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborators: ONO Pharmaceutical Co.; Ono Pharmaceutical Co. Ltd
• Treatments: Antibodies, Monoclonal; Cetuximab; Cisplatin; Nivolumab

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