Single-center phase 1-2 study of ramucirumab plus pembrolizumab for recurrent or metastatic head and neck squamous cell carcinoma

VEGF, a key mediator of angiogenesis and resistance to immunotherapy, is overexpressed in head and neck squamous cell carcinoma (HNSCC). Ramucirumab is a selective VEGFR2 inhibitor. A phase 1-2 study at Washington University in St Louis (MO) evaluated the combination of ramucirumab and pembrolizumab for recurrent or metastatic (R/M) HNSCC. In phase 1, no dose-limiting toxicity was seen. In phase 2, objective responses were seen in 18 of 33 evaluable patients (58%; 95% CI 38-70), including complete respons in 11 patients (33%), meeting the predefined criterion for activity. The most common grade 3 or 4 adverse events were dysphagia (38% of patients), lung infection (30%), and lymphocyte count decrease (27%). No treatment-related deaths were recorded. The authors conclude that the combination of ramucirumab and pembrolizumab was safe and active among patients with R/M HNSCC.