A Phase II Study of PD-1 Antibody SHR-1210 Combined With Apatinib of First-line Treatment of Advanced Acral Melanoma

Peking University Cancer Hospital & Institute2 sites in 1 country30 target enrollmentMarch 5, 2019

ConditionsMelanoma

InterventionsSHR1210 apatinib mesylate

Overview

Phase: Phase 2
Intervention: SHR1210
Conditions: Melanoma
Sponsor: Peking University Cancer Hospital & Institute
Enrollment: 30
Locations: 2
Primary Endpoint: ORR
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

the investigators launched this exploratory study to evaluate the objective response rate (ORR) of SHR-1210 combined with apatinib mesylate in the first-line treatment of patients with advanced acral melanoma.

Registry

clinicaltrials.gov

Start Date

March 5, 2019

End Date

April 10, 2021

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Peking University Cancer Hospital & Institute

Responsible Party

Principal Investigator

Jun Guo

Associate Director of Peking University Cancer Hospital

Peking University Cancer Hospital & Institute

Eligibility Criteria

Inclusion Criteria

•age:18-75 years, male or female.
•Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV).
•Has not received any systematic anti-tumor drug treatment.
•Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.
•Adequate organ function.
•Life expectancy of greater than 12 weeks.
•Patient has given written informed consent.

Exclusion Criteria

•Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
•Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
•Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
•Subjects with any active autoimmune disease or history of autoimmune disease
•Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
•Active infection or an unexplained fever \> 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
•Received a live vaccine within 4 weeks of the first dose of study medication.
•Pregnancy or breast feeding.
•Decision of unsuitableness by principal investigator or physician-in charge.