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

At a Glance

CategoryDetail
ConditionUnresectable cutaneous epithelial malignancies, including advanced cutaneous squamous cell carcinoma (cSCC) and non-cSCC NMSCs.
Key MechanismsNivolumab is an anti-PD-1 antibody that enhances immune response against tumors.
Target PopulationJapanese patients aged 20 years or older with advanced, histologically confirmed, incurable epithelial skin malignancies.
Care SettingMulticenter, open-label clinical trial.

Key Highlights

  • Nivolumab administered every 4 weeks for up to 26 cycles.
  • Study included patients with advanced cSCC and non-cSCC NMSCs.
  • First phase II trial evaluating PD-1 blockade in this population.

Guideline-Based Recommendations

Diagnosis

  • Histologically confirm advanced or recurrent epithelial skin malignancies.

Management

  • Nivolumab monotherapy for patients with advanced NMSC after surgical treatment and/or radiotherapy.

Monitoring & Follow-up

  • Regular assessment of response based on RECIST 1.1 criteria.

Risks

  • Exclusion of patients with severe allergies, autoimmune diseases, or recent thromboembolic events.

Patient & Prescribing Data

Patients aged 20 years or older with advanced, unresectable cutaneous epithelial malignancies.

Nivolumab may be extended for up to 2 years for patients achieving a response without disease progression.

Clinical Best Practices

  • Ensure informed consent and adherence to ethical guidelines.
  • Monitor organ function and performance status prior to treatment initiation.

References

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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