RTOG 3504

Primary Objectives for Phase I Lead In To evaluate the safety of the addition of nivolumab (anti PD-1 immunotherapy) to chemoradiotherapy with weekly cisplatin (40 mg/m2/week x 7) for patients with intermediate or high-risk head and neck squamous cell carcinoma (HNSCC) (Arm 1)To evaluate the safety of the addition of nivolumab (anti PD-1 immunotherapy) to chemoradiotherapy with high-dose cisplatin (100 mg/m2 q 21 days x 3) for patients with intermediate or high-risk head and neck squamous cell carcinoma (HNSCC) (Arm 2); To evaluate the safety of the addition of nivolumab (anti PD-1 immunotherapy) to chemoradiotherapy with weekly cetuximab (400 mg/m2 load, 250 mg/m2/week x 7) for patients with intermediate- or high-riskhead and neck squamous cell carcinoma (HNSCC) (Arm 3); To evaluate the safety of the addition of nivolumab (anti PD-1 immunotherapy) to radiotherapy for patients with intermediate or high-risk head and neck squamous cell carcinoma (HNSCC) with age > 70 years; Zubrod Performance Status 2; baseline grade ≥ 3 neuropathy; grade ≥2 hearing loss; or CrCl < 50 ml/min (Arm 4). Primary Objective for Phase III Trial To compare overall survival (OS) for patients with newly diagnosed, intermediate or high-risk local-regionally advanced HNSCC treated with cisplatin-based CRT with or without nivolumab.

July 03, 2017