NCT05106023

To Explore the Efficacy and Safety of SHR-1701 Combined With Temozolomide in the Treatment of Advanced Melanoma

A Prospective, Single-center Clinical Study to Explore the Efficacy and Safety of SHR-1701 Combined With Temozolomide in the Treatment of Advanced Melanoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (estimated)
• Sponsor: Yong Chen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to explore the efficacy and safety of SHR-1701 combined with temozolomide in the treatment of advanced melanoma.

Detailed description

This trial is a prospective, single-center, single-arm clinical research. Based on current experience, single agent immunotherapy has limited efficacy in advanced melanoma. SHR-1701 is a novel immunotherapy drug . Preclinical data suggest that temozolomide selectively depletes regulatory T cells. This potential immunomodulatory effect of temozolomide provides rationale for combination with SHR-1701. This study is aiming to evaluate the efficacy and safety of SHR-1701 combined with temozolomide in patients with advanced 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

Interventions

Type	Name	Description
DRUG	SHR-1701	SHR-1701 combined with temozolomide
DRUG	Temozolomide	SHR-1701 combined with temozolomide

Timeline

• Start date: 2022-01-21
• Primary completion: 2023-09-30
• Completion: 2023-12-31
• First posted: 2021-11-03
• Last updated: 2023-06-07

Locations

1 site across 1 country: China