NCT05827770

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Yong Chen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Melanoma Stage III

Interventions

Type	Name	Description
DRUG	Toripalimab combined with Temozolomide	Toripalimab combined with Temozolomide

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-12-31
• Completion: 2025-06-30
• First posted: 2023-04-25
• Last updated: 2023-04-25

Locations

1 site across 1 country: China