Pembrolizumab in Combination With Cisplatin and Intensity Modulated Radiotherapy (IMRT) in Head and Neck Cancer

Summary

The goal of this research study is to learn which therapy order (adding pembrolizumab during vs. after cisplatin and radiation) may be more effective in treating head and neck cancer, as well as learn the side effects of these combinations. Pembrolizumab is an immune therapy, a drug that stimulates the immune system to fight cancer, and is FDA approved in lung cancer and melanoma.

Timeline

Start

2016-05-31

Primary completion

2023-04-24

Completion

2023-05-04

Outcome

Met primary endpoint

paper Both arms met the trivariate primary end point PMID 40424564 ↗

Publications

• Zandberg DP, Vujanovic L, Clump DA, Isett BP, Wang H, Sica G, Bao R, Li H, Ohr J, Skinner HD, Seethala RR, Chiosea SI, Ferris RL, Bauman JE. Randomized Phase II Study of Concurrent Versus Sequential Pembrolizumab in Combination With Chemoradiation in Locally Advanced Head and Neck Cancer. J Clin Oncol. 2025 Aug 10;43(23):2572-2582. doi: 10.1200/JCO-24-01580. Epub 2025 May 27.
• Ferris RL, Moskovitz J, Kunning S, Ruffin AT, Reeder C, Ohr J, Gooding WE, Kim S, Karlovits BJ, Vignali DAA, Duvvuri U, Johnson JT, Petro D, Heron DE, Clump DA, Bruno TC, Bauman JE. Phase I Trial of Cetuximab, Radiotherapy, and Ipilimumab in Locally Advanced Head and Neck Cancer. Clin Cancer Res. 2022 Apr 1;28(7):1335-1344. doi: 10.1158/1078-0432.CCR-21-0426.

Drugs

Indications