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

Fudan University1 site in 1 country31 target enrollmentJune 20, 2020

ConditionsMucosal Melanoma

InterventionsToripalimab chemotherapy in combination with Endostar

DrugsToripalimab chemotherapy in combination with Endostar

Overview

Phase: Phase 2
Intervention: Toripalimab
Conditions: Mucosal Melanoma
Sponsor: Fudan University
Enrollment: 31
Locations: 1
Primary Endpoint: Progression-Free Survival, PFS
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 20, 2020

End Date

June 20, 2023

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Zhiguo Luo, MD, PhD

Clinical Professor

Fudan University

Eligibility Criteria

Inclusion Criteria

•Age 18-75 years, male or female；
•Histopathologically confirmed and diagnosed as mucosal melanoma;
•ECOG score 0 or 1;
•Life expectancy of at least 12 weeks；
•SD/PR/CR after chemotherapy in combination with Endostar;
•No contraindications, having adequate organ and marrow function；
•Use of highly-effective contraceptive methods during the whole study for men of reproduction ability or women of childbearing potential (e.g. oral contraceptives, intrauterine contraceptive device, abstinence of sexual intercourse or barrier contraception in combination with spermatocide), and continuation of contraception for 12 months after the end of treatment；
•The subject is voluntary to participate in the study, sign the informed consent form, with good compliance and willingness to cooperate with follow-up.

Exclusion Criteria

•Previously treated with anti-PD-1, anti-PD-L1, anti-PD-L2;
•Known allergy to recombinant humanized anti-PD-1 monoclonal antibody drug and its components;
•Skin melanoma, eye melanoma, melanoma with unknown primary foci;
•Symptomatic brain or meningeal metastases, unless the patient has been treated for \> 6 months, the imaging results are negative within 4 weeks before entering the study, and the clinical symptoms associated with the tumor are stable at the time of entering the study;
•Female patients who are pregnant or lactating, or of childbearing potential but not using appropriate contraceptive measures;
•Currently having serious and uncontrolled acute infection; or suppurative infection and chronic infection with prolonged wound healing;
•Having serious heart disorder, including cardiac failure congestive, uncontrollable high-risk arrhythmia, unstable angina pectoris, infarct myocardial, severe cardiac valve disease and refractory hypertension;
•Having neurological, mental disease or mental disorder that can not be easily controlled, poor compliance, inability to cooperate and narrate therapeutic response;
•Patients with other malignant tumors at the same time;
•Patients participated in other clinical trials at the same time;