NCT03941795

Phase II Study in the Treatment of Patients With Advanced Mucinous Melanoma

A Randomized, Controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection Combined With Axitinib in the First-Line Treatment of Patients With Advanced Mucosal Melanoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, controlled, multicenter Phase II clinical study to evaluate the efficacy and safety of toripalimab injection combined with axitinib in the first-line treatment of patients with advanced mucosal melanoma. The target population is the patients with previously untreated, histopathologically confirmed, unresectable or metastatic mucosal melanoma. At the randomization, patients are randomized 1:1:1 into three groups with approximately 33 subjects in each group to receive toripalimab injection plus axitinib, toripalimab injection monotherapy (subjects who meet the criteria after disease progression may cross over to receive toripalimab plus axitinib), or axitinib monotherapy (subjects who meet the criteria after disease progression may cross over to receive toripalimab plus axitinib); when the patient has disease progression or intolerable toxicity, the treatment is terminated, and the survival follow-up will be initiated.

Conditions

• Advanced Mucosal Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	JS001(Toripalimab Injection)	Test Group: Toripalimab (240 mg, IV, Q3W) + axitinib (5 mg/tablet, one tablet, twice a day, orally); axitinib is started on the second day of administration of toripalimab until disease progression or intolerable toxicity, the investigator or subject decides to withdraw, lost to follow-up, initiation of other antineoplastic therapy, or death, with a maximum duration of toripalimab use of no more than 2 years.
DRUG	Axitinib 1 MG [Inlyta]	Axitinib (5 mg/tablet) one tablet, twice a day, orally until disease progression or intolerable toxicity, the investigator or subject decides to withdraw, lost to follow-up, initiation of other antineoplastic therapy, or death
OTHER	JS001 and Axitinib	Control Group: Toripalimab (240 mg, IV, Q3W) is administered on the first day until disease progression or intolerable toxicity, the investigator or subject decides to withdraw, lost to follow-up, initiation of other antineoplastic therapy, or death, with a maximum duration of no more than 2 years

Timeline

• Start date: 2019-11-11
• Primary completion: 2022-06-01
• Completion: 2022-12-01
• First posted: 2019-05-08
• Last updated: 2019-12-06

Locations

2 sites across 1 country: China