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

NCT03602547 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-07-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • AnewPharma

    lead INDUSTRY

Principal Investigators

  • Jun Guo, M.D · Peking University Cancer Hospital & Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2019-07-31
Completion
2020-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03602547 on ClinicalTrials.gov