Phase III study of nivolumab alone or combined with ipilimumab as immunotherapy versus standard of care in resectable head and neck squamous cell carcinoma

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...

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Bibliographic Details
Published in:Future oncology (London, England) England), 2020-12, Vol.16 (36), p.3035-3043
Main Authors: Zech, Henrike B, Moeckelmann, Nikolaus, Boettcher, Arne, Muenscher, Adrian, Binder, Mascha, Vettorazzi, Eik, Bokemeyer, Carsten, Schafhausen, Philippe, Betz, Christian S, Busch, Chia-Jung
Format: Article
Language:English
Subjects:
Antibodies
Cancer therapies
Chemotherapy
Clinical trials
Disease
FDA approval
Head & neck cancer
head and neck cancer
Human papillomavirus
Immunotherapy
ipilimumab
Kidney cancer
Lung cancer
Medical prognosis
Melanoma
Metastasis
Monoclonal antibodies
nivolumab
Patients
PD-L1
Radiation therapy
randomized controlled trial
Squamous cell carcinoma
Standard of care
Surgery
Targeted cancer therapy
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Summary: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 ( )
ISSN:1479-6694
1744-8301
DOI:10.2217/fon-2020-0595