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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 Trial)
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).
Primary Objective(s): Objective: To determine whether RT with concurrent and adjuvant anti-PD1 therapy (pembrolizumab) is feasible in patients with intermediate/high risk p16+ locoregionally advanced head/neck cancer Phase II Objective: To test the hypothesis that pembrolizumab improves progression free survival (PFS) in this population compared to standard of care (RT plus cisplatin) Secondary Objectives Objective 1: To quantify acute and late toxicity, overall survival, radiographic response (at 4-month FDG-PET-CT), locoregional failure, distant metastasis, immune correlates, and competing mortality for RT/pembrolizumab compared to RT plus cisplatin in this population. Objective 2: To examine the relationships between age, baseline vulnerability score (as measured by the G-8 tool), and baseline competing event score (GCE-ω) and select outcomes including acute and late toxicity, locoregional control, distant metastasis, and overall survival. Exploratory Objective(s) & Hypothesis(es) Objective: To compare the outcomes with RT/pembrolizumab in patients with tumors as a function of PD-L1 expression.
Pembrolizumab (Keytruda); cisplatin ()