Cisplatin, 5-fluorouracil, and cetuximab (PFE) with or without cilengitide in recurrent/metastatic squamous cell carcinoma of the head and neck: results of the randomized phase I/II ADVANTAGE trial (phase II part). KEYNOTE-048 was a randomised, phase 3 study of participants with untreated locally incurable recurrent or metastatic HNSCC done at 200 sites in 37. 6000 Background: KEYNOTE-048 is a phase 3 study of P or P + chemo (C) vs EXTREME (E) as 1L therapy for R/M HNSCC (NCT02358031). Vermorken JB, Peyrade F, Krauss J, et al. KEYNOTE-048 - A Study of Pembrolizumab (MK-3475) for First Line Treatment of. Management of recurrent and metastatic oral cavity cancer: Raising the bar a step higher. Platinum-based chemotherapy plus cetuximab in head and neck cancer. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. KEYNOTE-048 was a phase 3 study evaluating pembrolizumab alone and in combination with chemotherapy in previously untreated R/M HNSCC. 10.1056/NEJMoa1602252īurtness B, Harrington KJ, Greil R, at al. Background: Here, we report the results of the Japanese subgroup of the phase 3 KEYNOTE-048 study of pembrolizumab alone, pembrolizumab plus platinum and 5-fluorouracil (pembrolizumab-chemotherapy), or cetuximab plus platinum and 5-fluorouracil (EXTREME) in previously untreated recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. Ferris RL, Blumenschein G, Jr, Fayette J, et al.
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