drugset

drugset / Trial / NCT03247712

Neoadjuvant Immunoradiotherapy in Head & Neck Cancer

NCT03247712 ↗

Phase 1/2 Active not recruiting 22 enrolled Providence Health & Services Providence Cancer Center, Earle A. Chiles Research Institute · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to test the safety of neoadjuvant immunoradiotherapy as a safe means of down-staging Head and Neck Squamous Cell Carcinoma (HNSCC) prior to surgical resection.

Timeline

Start: 2018-01-15
Primary completion: 2020-02-13
Completion: 2026-12

Publications

Leidner R, Crittenden M, Young K, Xiao H, Wu Y, Couey MA, Patel AA, Cheng AC, Watters AL, Bifulco C, Morris G, Rushforth L, Nemeth S, Urba WJ, Gough M, Bell RB. Neoadjuvant immunoradiotherapy results in high rate of complete pathological response and clinical to pathological downstaging in locally advanced head and neck squamous cell carcinoma. J Immunother Cancer. 2021 May;9(5):e002485. doi: 10.1136/jitc-2021-002485.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	240 mg	Intravenous
Subject	Nivolumab	Monoclonal antibody	480 mg	Intravenous

Indications