Pembrolizumab + Radiation for Locally Adv SCC of the Head and Neck (SCCHN) Not Eligible Cisplatin

Phase 2 Completed 29 enrolled UNC Lineberger Comprehensive Cancer Center Merck Sharp & Dohme LLC · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study is being done to evaluate the efficacy of Pembrolizumab, concomitant with and following standard of care definitive radiation, for locally advanced squamous cell carcinoma of the head and neck patients who are not good candidates for Cisplatin.

Timeline

Start: 2016-05-16
Primary completion: 2019-12-23
Completion: 2023-11-20

Outcome

Met primary endpoint

paper The primary PFS endpoint has exceeded the hypothesis and its median has not been reached. PMID 32371539 ↗

Publications

Weiss J, Sheth S, Deal AM, Grilley Olson JE, Patel S, Hackman TG, Blumberg JM, Galloway TJ, Patel S, Zanation AM, Shen CJ, Hayes DN, Hilliard C, Mehra R, McKinnon KP, Wang HH, Weissler MC, Bauman JR, Chera BS, Vincent BG. Concurrent Definitive Immunoradiotherapy for Patients with Stage III-IV Head and Neck Cancer and Cisplatin Contraindication. Clin Cancer Res. 2020 Aug 15;26(16):4260-4267. doi: 10.1158/1078-0432.CCR-20-0230. Epub 2020 May 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous