Nivolumab in the Treatment of Unresectable Cutaneous Epithelial Cancers: Results from a Phase II Open-Label, Single-Arm Multicenter Trial (NMSC-PD1) - Summary - MDSpire

Nivolumab in the Treatment of Unresectable Cutaneous Epithelial Cancers: Results from a Phase II Open-Label, Single-Arm Multicenter Trial (NMSC-PD1)

  • By

  • 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

  • March 4, 2026

  • 0 min

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Objective:

To evaluate the antitumour activity and safety of nivolumab monotherapy in Japanese patients with advanced non-melanoma skin cancers (NMSCs), specifically targeting both cutaneous squamous cell carcinoma (cSCC) and non-cSCC NMSCs.

Key Findings:
  • Nivolumab demonstrated antitumour activity in patients with advanced NMSCs, with a notable percentage of patients responding to treatment.
  • The treatment was generally well tolerated with manageable safety profiles.
Interpretation:

The results suggest that nivolumab may be a viable treatment option for advanced NMSCs in the Japanese population, addressing a significant unmet medical need.

Limitations:
  • The study was limited by its single-arm design, small sample size, and lack of a control group.
  • Results may not be generalizable to populations outside Japan.
Conclusion:

Nivolumab shows promise as an effective treatment for advanced cutaneous epithelial malignancies, warranting further investigation in larger, controlled trials to validate these findings.

Original Source(s)

Nivolumab in the Treatment of Unresectable Cutaneous Epithelial Cancers: Results from a Phase II Open-Label, Single-Arm Multicenter Trial (NMSC-PD1)

  • by 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

  • March 4, 2026

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