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Background <p>Data in East Asian patients and in other epithelial skin cancers, including extramammary Paget’s disease (EMPD) and adnexal carcinomas, are scarce. Therefore, we conducted a phase II trial of nivolumab in Japanese patients with advanced non-melanoma skin cancers (NMSCs).</p> Patients and methods <p>This multicentre, open-label, single-arm phase II study enrolled adults (≥ 20 years) with histologically confirmed unresectable or recurrent epithelial cutaneous malignancies, Eastern Cooperative Oncology Group performance status 0–1, and at least one measurable lesion (RECIST v1.1). Nivolumab 480&#xa0;mg was administered intravenously every 4 weeks for up to 26 cycles. The primary endpoint was overall response rate (ORR), assessed by blinded independent central review (BICR; RECIST v1.1). Secondary endpoints included progression-free survival, overall survival, and safety.</p> Results <p>Thirty-one patients were enrolled (20 cSCC, 4 EMPD, 2 BCC, 5 other NMSCs); median age was 73 years (range 58–86), and 71% were male. ORR by BICR was 22.6% (7/31), and the disease control rate was 54.8% (17/31). Responses were durable, with a median duration of 21.3 months. In the cSCC cohort, median tumour mutational burden (TMB) was 9.0 mut/Mb, lower than in Western series; among three patients with TMB ≥ 30 mut/Mb, two achieved objective responses. Common adverse events included pyrexia, hypothyroidism, adrenal insufficiency, and pruritus.</p> Conclusions <p>Nivolumab showed durable antitumour activity with manageable toxicity in Japanese patients with advanced NMSCs, including rare non-cSCC. The lower ORR compared with Western trials may reflect intrinsic biological differences and support biomarker-driven, region-specific immunotherapy.</p> Clinical trial registration <p>jRCT2031190048; registered 2 July 2019.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月4日

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  • Yoshio Nakamura,
  • Naoya Yamazaki,
  • Kenjiro Namikawa,
  • Hiroshi Uchi,
  • Shoichiro Mori,
  • Mariko Ogawa-Momohara,
  • Taku Fujimura,
  • Tatsuya Takenouchi,
  • Mana Kurimoto,
  • Yuki Yamamoto,
  • Atsushi Otsuka,
  • Kenji Kabashima,
  • Takayuki Fusumae,
  • Ikuko Hirai,
  • Keiji Tanese,
  • Yasuko Saito,
  • Masayuki Amagai,
  • Ryo Takemura,
  • Yasunori Sato,
  • Takeru Funakoshi

摘要

Background

Data in East Asian patients and in other epithelial skin cancers, including extramammary Paget’s disease (EMPD) and adnexal carcinomas, are scarce. Therefore, we conducted a phase II trial of nivolumab in Japanese patients with advanced non-melanoma skin cancers (NMSCs).

Patients and methods

This multicentre, open-label, single-arm phase II study enrolled adults (≥ 20 years) with histologically confirmed unresectable or recurrent epithelial cutaneous malignancies, Eastern Cooperative Oncology Group performance status 0–1, and at least one measurable lesion (RECIST v1.1). Nivolumab 480 mg was administered intravenously every 4 weeks for up to 26 cycles. The primary endpoint was overall response rate (ORR), assessed by blinded independent central review (BICR; RECIST v1.1). Secondary endpoints included progression-free survival, overall survival, and safety.

Results

Thirty-one patients were enrolled (20 cSCC, 4 EMPD, 2 BCC, 5 other NMSCs); median age was 73 years (range 58–86), and 71% were male. ORR by BICR was 22.6% (7/31), and the disease control rate was 54.8% (17/31). Responses were durable, with a median duration of 21.3 months. In the cSCC cohort, median tumour mutational burden (TMB) was 9.0 mut/Mb, lower than in Western series; among three patients with TMB ≥ 30 mut/Mb, two achieved objective responses. Common adverse events included pyrexia, hypothyroidism, adrenal insufficiency, and pruritus.

Conclusions

Nivolumab showed durable antitumour activity with manageable toxicity in Japanese patients with advanced NMSCs, including rare non-cSCC. The lower ORR compared with Western trials may reflect intrinsic biological differences and support biomarker-driven, region-specific immunotherapy.

Clinical trial registration

jRCT2031190048; registered 2 July 2019.