NCT03602547

Study of the Combination of CM082 With JS001 in Patients With Advanced Mucosal Melanoma.

Phase II Clinical Study of CM082 Combined With JS001 in the Treatment of Advanced Mucosal Melanoma.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: AnewPharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study was a one-arm, single-center, phase II clinical study. Patients who meet the enrollment criteria will receive CM082 tablets 200mg once daily (qd) orally (taken within half an hour after daily breakfast) in combination with JS001 (3mg/kg, once every 2 weeks, q2w), every 28 days a treatment cycle until the disease progresses , the toxicity is intolerable, the investigator or subject decides to withdraw, loses to follow up, starts using other anti-tumor treatments or dies.

Conditions

• Mucosal Melanoma

Interventions

Type	Name	Description
DRUG	CM082 plus JS001	CM082：200mg once a day (qd) orally (taken within half an hour after breakfast). JS001 :An intravenous infusion of a solution having a concentration of 1-10 mg/ml was prepared with 0.9% physiological saline, and administered once every two weeks. Using an inline filter (0.2 or 0.22 μm), the drug was diluted with physiological saline and intravenously administered within 60 minutes.

Timeline

• Start date: 2018-07-31
• Primary completion: 2019-07-01
• Completion: 2020-06-01
• First posted: 2018-07-27
• Last updated: 2019-07-05

Locations

1 site across 1 country: China