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

Completed · Phase 3

Conditions studied: Squamous Cell Carcinoma of the Head and Neck

In brief

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

Key facts

Study ID

NCT03349710

Run by

Bristol-Myers Squibb

People needed

74

Starts

2017-12-15

Expected to finish

2019-10-14

Last updated by the study team

2021-08-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cancer Treatment Centers of Phoneix — Goodyear, Arizona, United States
• University of Arizona Cancer Center — Tucson, Arizona, United States
• UCLA Health — Los Angeles, California, United States
• Cancer Care - Torrance Memorial Physician Network — Redondo Beach, California, United States
• Cancer Center of Central Connecticut — Plainville, Connecticut, United States
• Orlando Health, Inc — Orlando, Florida, United States
• Winship Cancer Insitute, Emory Crawford Long Hospital — Atlanta, Georgia, United States
• CTCA Southeastern Region — Newnan, Georgia, United States
• Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital — Thomasville, Georgia, United States
• Midwestern Regional medical Center — Zion, Illinois, United States
• Fort Wayne Medical Oncology and Hematology, Inc. — Fort Wayne, Indiana, United States
• University of Kansas Cancer Center — Westwood, Kansas, United States
• Nebraska Methodist Hospital — Omaha, Nebraska, United States
• Monter Cancer Center - Center for Advanced Medicine Location — Lake Success, New York, United States
• Eastern Regional Medical Center — Philadelphia, Pennsylvania, United States
• Upmc- Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• St. Joseph Regional Cancer Center — Bryan, Texas, United States
• The University of Texas MD Anderson Cancer Center-merge — Houston, Texas, United States
• Inova Health System — Falls Church, Virginia, United States
• HHP Hematology & Oncology Bremerton — Bremerton, Washington, United States
• Local Institution — Grenoble, France
• Local Institution — Marseille, France
• Local Institution — Nice, France
• Local Institution — Lucca, Italy
• Pinnacle Research Group, Llc — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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