Postoperative adjuvant radiochemotherapy with cisplatin versus adjuvant radiochemotherapy with cisplatin and pembrolizumab in locally advanced head and neck squamous cell carcinoma- the study protocol of the Adrisk trial.

Most of the patients with head and neck squamous cell carcinoma (HNSCC) are diagnosed with locally advanced disease. Standards of care for curative-intent treatment of this patient group are either surgery and adjuvant radio(chemo)therapy (aRCT) or definitive chemoradiation. Despite these treatments, especially pathologically intermediate and high-risk HNSCC often recur. The ADRISK trial investigates in locally advanced HNSCC and intermediate and high risk after up-front surgery if the addition of pembrolizumab to aRCT with cisplatin improves event-free sur-vival compared to aRCT alone. ADRISK is a prospective, randomized controlled investiga-tor-initiated (IIT)-phase II multicenter trial within the German Interdisciplinary Study Group of German Cancer Society (IAG-KHT). Patients with primary resectable stage III and IV HNSCC of the oral cavity, oropharynx, hypopharynx and larynx with pathologic high (R1, extracapsular nodal extension) or intermediate risk (R0 <5 mm; N≥2) after surgery will be eligible. Two hun-dred forty patients will be randomly assigned (1:1) to either standard aRCT with cisplatin (standard arm) or aRCT with cisplatin + pembrolizumab (200 mg iv, in 3-week cycle, max. 12 months) (interventional arm). Endpoints are event-free and overall survival. Recruitment started in August 2018 and is ongoing.
Competing Interests: SW declares remuneration for scientific presentations or participation on Advisory Boards for MSD, BMS, Merck Serono, Roche, Astra Zeneca, Sanofi, GSK. FL reports grants from Bristol Myers Squibb and Gilead paid to his institution. Consulting fees from Amgen, Astellas, AstraZeneca, Bristol Myers Squibb, Daichi Sankyo, Lilly, Merck Merck Sharpe & Dohme, Novartis, Roche, and Servier; payment or honoraria for educational lectures and seminars from Art Tempi, AstraZeneca, Beigene, Bristol Myers Squibb, Elsevier, Incyte, Lilly, Medscape, Medupdate GmbH, Merck KGaA, Merck Merck Sharpe & Dohme, Roche, Servier, Springer-Nature, and Streamedup! Support for attending meetings or travel from Roche and Bristol Myers Squibb. PB was participant in Advisory Boards for BMS, MSD, AstraZeneca and Amgen, received honoraria for lectures from MSD, BMS, AstraZeneca and Novartis and research support from BMS. GM: Honoraria for lectures from AMGEN, Gilead, Merck-Serono and Janssen-Cilag. Member of Guideline Writing Committees: German Society for Haematology and Medical Oncology, German Cancer Society. GH reports honoraria from MSD advisory role, BMS advisory role, Roche advisory role. BT reports honoraria from BMS advisory role. Merck Serono advisory role, speakers’ bureau, honoraria. MSD advisory role, speakers’ bureau, honoraria. Sanofi advisory role. AD reports remuneration for scientific presentations and participation on Advisory Boards for Merck Serono, Roche, Astra Zeneca, MSD, BMS, Sanofi, Norgine, Nanobiotix and GSK and research support from Roche, Merck Serono and MSD. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be constructed as a potential conflict of interest.
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