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).
Keywords:
PD-L1; head and neck cancer; ipilimumab; nivolumab; randomized controlled trial.
Publication types
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Clinical Trial, Phase III
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Comparative Study
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Randomized Controlled Trial
MeSH terms
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Adult
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Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
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Antineoplastic Combined Chemotherapy Protocols / adverse effects
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CTLA-4 Antigen / antagonists & inhibitors
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CTLA-4 Antigen / metabolism
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Chemoradiotherapy, Adjuvant / adverse effects
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Chemoradiotherapy, Adjuvant / methods
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Chemotherapy, Adjuvant / adverse effects
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Chemotherapy, Adjuvant / methods
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Cisplatin / administration & dosage
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Cisplatin / adverse effects
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Disease-Free Survival
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Female
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Fluorouracil / administration & dosage
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Fluorouracil / adverse effects
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Head and Neck Neoplasms / diagnosis
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Head and Neck Neoplasms / immunology
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Head and Neck Neoplasms / mortality
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Head and Neck Neoplasms / therapy*
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Humans
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Immune Checkpoint Inhibitors / administration & dosage*
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Immune Checkpoint Inhibitors / adverse effects
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Ipilimumab / administration & dosage
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Ipilimumab / adverse effects
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Male
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Middle Aged
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Mitomycin / administration & dosage
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Mitomycin / adverse effects
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Neoadjuvant Therapy / adverse effects
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Neoadjuvant Therapy / methods*
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Neoplasm Recurrence, Local / epidemiology*
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Neoplasm Recurrence, Local / immunology
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Neoplasm Recurrence, Local / prevention & control
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Neoplasm Staging
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Nivolumab / administration & dosage
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Nivolumab / adverse effects
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Programmed Cell Death 1 Receptor / antagonists & inhibitors
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Programmed Cell Death 1 Receptor / metabolism
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Prospective Studies
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Squamous Cell Carcinoma of Head and Neck / diagnosis
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Squamous Cell Carcinoma of Head and Neck / immunology
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Squamous Cell Carcinoma of Head and Neck / mortality
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Squamous Cell Carcinoma of Head and Neck / therapy*
Substances
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CTLA-4 Antigen
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CTLA4 protein, human
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Immune Checkpoint Inhibitors
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Ipilimumab
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PDCD1 protein, human
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Programmed Cell Death 1 Receptor
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Nivolumab
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Mitomycin
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Cisplatin
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Fluorouracil
Associated data
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ClinicalTrials.gov/NCT03700905