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Anti-PD-1 antibody therapy for epithelial skin malignancies: An investigator-initiated, open-label, single-arm,
Maki Ishii1, Ikuko Hirai1, Keiji Tanese1
1Department of Dermatology, Keio University School of Medicine, Tokyo.
Introduction:
Malignant cutaneous epithelial tumors comprise various skin malignancies originating from the cutaneous epithelium, including cutaneous squamous cell carcinoma, basal cell carcinoma, and malignant cutaneous adnexal tumors. Treatment options are limited, as the rarity of these tumors, especially among Asians, renders well-controlled clinical trials extremely challenging to conduct. Thus, we designed a clinical trial to evaluate the efficacy and safety of the anti-programmed cell death-1 (PD-1) monoclonal antibody nivolumab in patients with metastatic cutaneous squamous cell carcinomas and other rare metastatic cutaneous epithelial tumors.
Methods And Analysis:
This is an open-label, single-arm, multicenter, phase 2 clinical trial involving patients with metastatic malignant cutaneous epithelial tumors. Nivolumab (480 mg) will be administered intravenously every 4 weeks for a maximum of 26 doses. The primary outcome of the study will be the response rate based on response evaluation criteria in solid tumors, version 1.1. Assuming a null hypothesis of a response rate ≤5% and an alternative hypothesis of a 25% response rate, a minimum of 26 patients are required to achieve a 5% two-sided type I error and 80% power based on the exact binomial distribution. Finally, a target cohort size of 30 patients was determined as some patient dropout will be expected.
Discussion:
This is the first phase 2 clinical trial evaluating the efficacy and safety of the PD-1 inhibitor nivolumab in Asian patients with metastatic malignant cutaneous epithelial tumors. The findings of the study will contribute to the development of novel treatment approaches for patients with rare cutaneous malignancies, which remains an unmet clinical need.
Trial Registration:
Registry number: jRCT 2031190048.
Insights
This study investigates nivolumab, an anti-programmed cell death-1 (PD-1) antibody, for rare metastatic skin cancers in Asian patients. Findings may offer new treatment options for these challenging malignancies.
Area of Science:
- Oncology
- Dermatology
- Immunotherapy
Background:
- Malignant cutaneous epithelial tumors are rare skin cancers with limited treatment options, especially in Asian populations.
- Conducting clinical trials for these rare tumors is challenging due to small patient numbers.
- Metastatic cutaneous squamous cell carcinoma and other rare skin malignancies represent an unmet clinical need.
Purpose of the Study:
- To evaluate the efficacy and safety of nivolumab, an anti-programmed cell death-1 (PD-1) monoclonal antibody.
- To assess nivolumab's potential as a treatment for Asian patients with metastatic malignant cutaneous epithelial tumors.
- To address the lack of effective therapies for rare cutaneous malignancies.
Main Methods:
- An open-label, single-arm, multicenter, phase 2 clinical trial.
- 30 patients with metastatic malignant cutaneous epithelial tumors will receive nivolumab (480 mg IV every 4 weeks for up to 26 doses).
- The primary outcome is the response rate assessed by Response Evaluation Criteria in Solid Tumors version 1.1.
Main Results:
- This section is not available in the provided abstract.
- The study is designed to detect a response rate of 25% versus a null hypothesis of 5% with 80% power.
- Patient dropout is accounted for in the target cohort size of 30.
Conclusions:
- This is the first phase 2 clinical trial assessing nivolumab in Asian patients with metastatic malignant cutaneous epithelial tumors.
- The study aims to provide crucial data on the efficacy and safety of PD-1 inhibition for rare skin cancers.
- Findings are expected to contribute to developing novel treatment strategies for patients with rare cutaneous malignancies.
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