Abstract 707TiP
Background
PD-1 immune checkpoint inhibitors have been approved for treatment of head and neck squamous cell carcinoma (HNSCC) in recurrent/metastatic settings as they significantly improve patients’ overall survival (OS). The next step is to explore the efficacy of immune checkpoint inhibitors in the curative setting, especially in patients with locoregional, pathologically intermediate and high-risk HNSCC which recur frequently despite adjuvant cisplatin-based radiochemotherapy (aRCH). Based on this rationale, we have developed the ADRISK trial to investigate the addition of pembrolizumab to standard aRCH in the treatment of patients with locally advanced intermediate- and high-risk HNSCC. Given the unmet need for reducing high rates of relapse in this patient group by improved adjuvant treatment, we expect that ADRISK will provide new insights into treatment and might demonstrate the ability of pembrolizumab to improve survival.
Trial design
ADRISK is a prospective, multicenter, randomized controlled phase II trial within the German Interdisciplinary Study Group of German Cancer Society. 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 who are eligible for cisplatin-based aRCH after surgery will receive either standard aRCH with cisplatin versus the same treatment + pembrolizumab (200 mg iv, in 3-week cycle, max. 12 months). The objectives are to show that addition of pembrolizumab to postoperative adjuvant cisplatin-based RCH improves event-free survival and OS compared with aRCH alone in locally advanced intermediate and high-risk HNSCC. To our knowledge, this is the only multicenter, randomized trial analyzing the addition of pembrolizumab to aRCH in this patient group without prior neoadjuvant treatment. Recruitment started in August 2018 and is ongoing. Until April 2022, 163 patients were registered for the trial and 157 patients were randomized. The planned sample size is 240 patients, the recruitment is estimated to be completed by July 2024 at the latest.
Clinical trial identification
NCT03480672.
Editorial acknowledgement
Legal entity responsible for the study
University of Leipzig.
Funding
MSD.
Disclosure
S. Wiegand: Financial Interests, Personal, Invited Speaker: MSD, BMS, Merck Serono, AstraZeneca, Roche; Financial Interests, Personal, Advisory Board: MSD, BMS, Merck Serono, Sanofi Aventis. B.F. Tamaskovics: Financial Interests, Personal, Invited Speaker: Merck Darmstadt; Financial Interests, Personal, Advisory Board: BMS, Merck Darmstadt, Sanofi; Financial Interests, Institutional, Invited Speaker: MSD, BMS, AstraZeneca; Non-Financial Interests, Institutional, Product Samples: KLS Martin Group, Tuttlingen, Germany. P. Brossart: Financial Interests, Personal, Invited Speaker: BMS, MSD; Financial Interests, Personal, Writing Engagements: BMS; Financial Interests, Personal, Advisory Board: BMS, Amgen, AstraZeneca; Financial Interests, Personal, Funding: Amgen. G. Maschmeyer: Financial Interests, Personal, Invited Speaker: BMS, Amgen, AstraZeneca, Janssen-Cilag, University Hospital Leipzig, University Hospital Kiel, Klinikum Bamberg, Karolinska Hospital Stockholml, Swedish Society for Hematology, Kliniken Essen Sued, MedUpdate GmbH, Diako Klinik Bremen, Apothekerkammer Baden-Württemberg, FOMF GmbH, RG Medizinische Fortbildung, OSHO Service GmbH, Labor 28 Berlin, Merck Serono; Non-Financial Interests, Personal, Invited Speaker: Wilsede Schule für Onkologie, Best Practice Onkologie, EBMT, DGHO, University Hospital Greifswald, ECIL, Charite Berlin, Deutsche Leukämie Hilfe, Mitteldeutsche Geselschaft für Pneumologie, Berufsverband der Deutschen Chirurgen, LAGO Brandenburg, Deutsche Krebsgesellschaft, Deutsche Gesellschaft für HNO-Heilkunde; Non-Financial Interests, Personal, Expert Testimony: Arzneimittelkommission der Deutschen Ärzteschaft, Gemeinsamer Bundesausschuss, DGHO. T.C. Gauler: Financial Interests, Personal and Institutional, Invited Speaker: MSD; Financial Interests, Personal and Institutional, Writing Engagements: MSD; Financial Interests, Personal, Invited Speaker: Merck Serono, BMS, AstraZeneca; Financial Interests, Personal, Advisory Board: Merck Serono, BMS, AstraZeneca; Financial Interests, Personal, Stocks/Shares: Bayer AG. O. Guntinas-Lichius: Financial Interests, Personal, Invited Speaker: Novartis, Merz, MedEL; Financial Interests, Personal, Advisory Board: Merz; Financial Interests, Personal and Institutional, Research Grant: MedEL; Financial Interests, Personal and Institutional, Funding: MedEL. G. Hapke: Financial Interests, Personal, Invited Speaker: Roche, AbbVie; Financial Interests, Personal and Institutional, Writing Engagements: Roche; Financial Interests, Personal and Institutional, Funding: MSD, BMS, Biotech, GSK, Gilead. S. Dommerich: Financial Interests, Personal, Invited Speaker: Sanofi Aventis, BMS; Financial Interests, Personal, Advisory Board: Sanofi Aventis; Financial Interests, Personal, Funding: BMS. A. Schmiedeknecht: Non-Financial Interests, Institutional, Funding: MSD. G. Wichmann: Financial Interests, Institutional, Funding: MSD; Financial Interests, Institutional, Product Samples: MSD. A. Dietz: Financial Interests, Personal and Institutional, Funding: Roche, Merck Serono; Financial Interests, Personal, Invited Speaker: Merck Serono, Roche, AstraZeneca, BMS, MSD, Novartis, Sanofi, GSK, Nanobiotix; Financial Interests, Personal, Advisory Board: Merck Serono, Roche, AstraZeneca, BMS, MSD, Novartis, Sanofi, GSK, Nanobiotix. All other authors have declared no conflicts of interest.