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The Efficacy and Safety of Neoadjuvant Toripalimab Combined With Temozolomide in Resectable Stage III Melanoma

Melanoma Stage III Clinical Trial

Official title:
The Efficacy and Safety of Neoadjuvant Toripalimab Combined With Temozolomide in Resectable Stage III Melanoma: A Prospective, Single-center, Phase 2 Clinical Trial

Clinical Trial Summary

This study is being conducted to explore the efficacy and safety of neoadjuvant toripalimab combined with temozolomide in resectable stage III melanoma.

Clinical Trial Description

This trial is a prospective, single-center, single-arm clinical research. Unlike seen in Caucasians, checkpoint inhibitors have not obtained satisfactory results in Chinese patients. Exploring the curative effects of combination therapies in melanoma and their potential synergetic mechanism will improve the prognosis of patients. Recent retrospective data in our center showed that the objective response rate (ORR) of immunotherapy plus chemotherapy in advanced melanoma reached 40%, which was higher than immunotherapy (12.5%) and chemotherapy (4%) alone as front-line therapies. This study is aiming to evaluate the efficacy and safety of toripalimab combined with temozolomide in patients with resectable stage III melanoma. The safety and efficacy of this study will be assessed through ORR, DCR, PFS, OS, and adverse effects as graded by CTCAE 5.0. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05827770
Study type Interventional
Source Fudan University
Contact Yong Chen, MD
Phone 18017317571
Email chenyong@fudan.edu.cn
Status Not yet recruiting
Phase Phase 2
Start date May 1, 2023
Completion date June 30, 2025
View Details
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