NCT04472806

Maintenance Treatment of Toripalimab(JS001) in Patients With Unresectable Locally Advanced or Metastatic Mucosal Melanoma

A Multicenter, Single-arm, Open, Phase II Clinical Study on the Efficacy and Safety of Toripalimab(JS001) After Chemotherapy in Combination With Endostar in Patients With Unresectable Locally Advanced or Metastatic Mucosal Melanoma

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

Summary

This study is a multicenter, single-arm, open, phase Ⅱ clinical study to evaluate the safety and efficacy of Toripalimab(JS001) monoclonal injection after chemotherapy in combination with Endostar for Locally Advanced or Metastatic Mucosal Melanoma.

Conditions

• Mucosal Melanoma

Interventions

Type	Name	Description
DRUG	Toripalimab	Toripalimab, humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically. Toripalimab treatment after chemotherapy in combination with Endostar, 240 mg, Q3W, up to 2 years.
DRUG	chemotherapy in combination with Endostar	chemotherapy+ Endostar

Timeline

• Start date: 2020-06-20
• Primary completion: 2022-06-20
• Completion: 2023-06-20
• First posted: 2020-07-15
• Last updated: 2020-07-15

Locations

1 site across 1 country: China