1. Phase III study of nivolumab alone or combined with ipilimumab as immunotherapy versus standard of care in resectable head and neck squamous cell carcinoma
- Author
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Adrian Muenscher, Philippe Schafhausen, Henrike Barbara Zech, Nikolaus Moeckelmann, Mascha Binder, Arne Boettcher, Christian Stephan Betz, Chia-Jung Busch, Eik Vettorazzi, and Carsten Bokemeyer
- Subjects
Adult ,Male ,Oncology ,Cancer Research ,medicine.medical_specialty ,Mitomycin ,Programmed Cell Death 1 Receptor ,Ipilimumab ,Disease-Free Survival ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,Adjuvant therapy ,Clinical endpoint ,Humans ,Medicine ,CTLA-4 Antigen ,Prospective Studies ,030223 otorhinolaryngology ,Immune Checkpoint Inhibitors ,Neoplasm Staging ,Squamous Cell Carcinoma of Head and Neck ,business.industry ,Head and neck cancer ,Chemoradiotherapy, Adjuvant ,General Medicine ,Middle Aged ,medicine.disease ,Head and neck squamous-cell carcinoma ,Neoadjuvant Therapy ,Clinical trial ,stomatognathic diseases ,Nivolumab ,Chemotherapy, Adjuvant ,Head and Neck Neoplasms ,030220 oncology & carcinogenesis ,Female ,Fluorouracil ,Cisplatin ,Neoplasm Recurrence, Local ,business ,medicine.drug - Abstract
Locally advanced head and neck squamous cell carcinoma (LA-HNSCC) often requires postoperative chemoradiation with high risk of toxicity. Disease-free survival (DFS) after 2 years is approximately 70%. Combining nivolumab (N), a PD-1-inhibitor and ipilimumab (I), a CTLA4- inhibitor, may improve DFS due to antitumor effects of immunotherapy. The IMSTAR-HN study compares neoadjuvant N and N ± I 6 months after adjuvant therapy versus standard therapy as first-line treatment for LA-HNSCC. Eligible patients have treatment-naive LA-HNSCC, Eastern cooperative oncology group performance score (PS) ≤1 and no distant metastasis. 276 patients will be randomized into two arms. Primary endpoint is DFS and secondary endpoint includes locoregional control (LRC) and overall survival (OS). This study is one of the first in HNSCCs implementing immunotherapy in first-line treatment in a curative setting. Clinical Trial Registration: NCT03700905 ( ClinicalTrials.gov )
- Published
- 2020
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