NCT03349710

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	Specified dose on specified day
DRUG	Cetuximab	Specified dose on specified day
DRUG	Cisplatin	Specified dose on specified day
RADIATION	Radiotherapy	Specified dose on specified day

Timeline

• Start date: 2017-12-15
• Primary completion: 2019-10-14
• Completion: 2019-10-14
• First posted: 2017-11-21
• Last updated: 2021-08-09
• Results posted: 2021-08-09

Locations

55 sites across 10 countries: United States, France, Italy, Japan, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study