Randomized phase II trial of nivolumab with stereotactic body radiotherapy vs nivolumab alone in metastatic head and neck squamous cell carcinoma
Journal of Clinical Oncology — McBride S, Sherman E, Tsai CJ, et al. | August 25, 2020
Given that the objective response rate for single-agent anti-programmed death receptor 1 (anti–PD-1) therapy is modest in patients with metastatic or recurrent head and neck squamous cell carcinoma (HNSCC), researchers ascertained if radiotherapy may act synergistically with anti–PD-1 therapy to improve response through the abscopal effect. They performed a single-center, randomized, phase II trial of nivolumab (anti–PD-1 therapy) vs nivolumab plus stereotactic body radiotherapy (SBRT) in patients with metastatic HNSCC. Study participants were randomly assigned (1:1), stratified by human papillomavirus status, to nivolumab (3 mg/kg intravenously every 2 weeks) or nivolumab (same dose) plus SBRT (9 Gy × 3) to 1 lesion. Sixty-two patients were randomly assigned to nivolumab (n = 30) or nivolumab plus SBRT (n = 32) between March 11, 2016, and June 22, 2018. In unselected patients with metastatic HNSCC, there was no improvement in response and no evidence of an abscopal effect with the addition of SBRT to nivolumab.