NCT04462965

Postoperative Adjuvant Treatment of Completely Resected Mucosal Melanoma Phase II Study

A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Combined With Temozolomide and Cisplatin in the Postoperative Adjuvant Treatment of Completely Resected Mucosal Melanoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 294 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A mucosal melanoma postoperative adjuvant treatment of multicenter, randomized, double-blind, placebo-controlled phase II study, evaluation of mucosal melanoma patients accept completely resected, Toripalima Combined with Temozolomide and Cisplatin postoperative adjuvant therapy efficacy and safety

Conditions

• Mucosal Melanoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Toripalimab	Injection,Specification 240mg/6ml, 3 mg/kg for the dose, iV, every 2 weeks a dose cycle, up to 1 year; Temozolomide: 100mg or 20mg, Every 4 weeks a dose cycle, up to 6 cycles Cisplatin: Injection, 20mg,Every 4 weeks a dose cycle, up to 6 cycles
COMBINATION_PRODUCT	Temozolomide	Placebo：Injection,Specification 240mg/6ml, 3 mg/kg for the dose, iV, every 2 weeks a dose cycle, up to 1 year; Temozolomide: 100mg or 20mg, Every 4 weeks a dose cycle, up to 6 cycles Cisplatin: Injection, 20mg,Every 4 weeks a dose cycle, up to 6 cycles

Timeline

• Start date: 2020-05-30
• Primary completion: 2024-11-30
• Completion: 2025-06-30
• First posted: 2020-07-08
• Last updated: 2022-01-25

Locations

1 site across 1 country: China