NCT02764593

Safety Testing of Adding Nivolumab to Chemotherapy in Patients With Intermediate and High-Risk Local-Regionally Advanced Head and Neck Cancer

Safety Evaluations of Nivolumab (Anti-PD-1) Added To Chemotherapy (CRT) Platforms In Patients With Intermediate And High-Risk Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: RTOG Foundation, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety of adding nivolumab to several chemotherapy platforms with weekly cisplatin, high-dose cisplatin, cetuximab or radiation therapy alone.

Conditions

• Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions

Type	Name	Description
DRUG	Nivolumab	Anti-PD-1 targeted immunotherapy
DRUG	Cisplatin	Anti-cancer alkylating agent
DRUG	Cetuximab	Epidermal Growth Factor Receptor (EGFR) antagonist
RADIATION	IMRT	High-precision radiotherapy

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-09-25
• Completion: 2022-02-21
• First posted: 2016-05-06
• Last updated: 2022-11-29

Locations

11 sites across 1 country: United States