Spots Global Cancer Trial Database for Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer

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Trial Identification

Brief Title: Chemoradiation vs Immunotherapy and Radiation for Head and Neck Cancer

Official Title: Phase II Randomized Trial of Radiotherapy With Concurrent and Adjuvant Pembrolizumab (Keytruda®) Versus Concurrent Chemotherapy in Patients With Advanced/Intermediate-Risk p16+ Head and Neck Squamous Cell Carcinoma (KEYCHAIN)

Study ID: NCT03383094

Conditions

Head and Neck Squamous Cell Carcinoma

Cancer

Cancer of Head and Neck

Oropharynx Cancer, Stage III

Oropharynx Cancer, Recurrent

Oropharynx Cancer, Metastatic

Interventions

Pembrolizumab

Radiation therapy

Cisplatin

Study Description

Brief Summary: The purpose of this study is to compare any good or bad effects of using pembrolizumab (an experimental drug) and radiation therapy (RT), compared to using cisplatin chemotherapy and radiation therapy (RT) in the treatment of patients with head and neck squamous cell carcinoma (HNSCC).

Detailed Description: This study is a prospective, multi-institutional, open-label, randomized phase II trial that will evaluate the efficacy of concurrent and adjuvant pembrolizumab with radiation therapy (RT) versus RT plus cisplatin in intermediate/high-riskp16-positive locoregionally advanced head and neck squamous cell carcinoma (HNSCC). The primary endpoint is progression-free survival (PFS).