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March 6, 2026BMC CancerOpen Access

Nivolumab for unresectable cutaneous epithelial malignancies: an open-label, single-arm, multi-centre, phase II trial (NMSC-PD1)

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Authors

YNYoichi NakamuraNYNaoya YamazakiKNK. Namikawa

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Overview

Phase II trial assesses nivolumab's effectiveness in treating advanced non-melanoma skin cancers, suggesting region-specific strategies.

Key Points

  • The study aims to evaluate the effectiveness and safety of nivolumab in treating advanced non-melanoma skin cancers in Japanese patients.
  • Open-label, single-arm, multi-centre phase II trial
  • Enrolled adults with unresectable or recurrent epithelial malignancies
  • Administered nivolumab 480 mg intravenously every 4 weeks for up to 26 cycles
  • Measured overall response rate via blinded independent central review
  • Overall response rate was 22.6% among enrolled patients
  • Disease control rate was 54.8%, with durable responses lasting a median of 21.3 months
  • Median tumour mutational burden in cSCC cohort was 9.0 mut/Mb
  • Adverse events included pyrexia, hypothyroidism, adrenal insufficiency

Cite This Study

Nakamura et al. (2026) studied this question.

synapsesocial.com/papers/69aa70f8531e4c4a9ff5b379https://doi.org/10.1186/s12885-026-15829-2
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