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

May 16, 2019 updated by: Jun Guo, Peking University Cancer Hospital & Institute

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beijing, China
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Guo Jun
        • Contact:
          • Jun Guo, MD
          • Phone Number: 01088121122 010-88121122
          • Email: guoj307@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age:18-75 years, male or female.
  2. Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV).
  3. Has not received any systematic anti-tumor drug treatment.
  4. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
  5. ECOG 0-1.
  6. Adequate organ function.
  7. Life expectancy of greater than 12 weeks.
  8. Patient has given written informed consent.

Exclusion Criteria:

  1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
  2. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
  3. Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
  4. Subjects with any active autoimmune disease or history of autoimmune disease
  5. 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;
  6. 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);
  7. Received a live vaccine within 4 weeks of the first dose of study medication.
  8. Pregnancy or breast feeding.
  9. Decision of unsuitableness by principal investigator or physician-in charge.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental arm
SHR1210 plus apatinib
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
apatinib Mesylate is a small molecule tyrosine kinase inhibitor,Through selectively inhibiting the tyrosine kinase activity of the vascular endothelial growth factor receptor 2 (VEGFR-2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: Time Frame: Through study completion, an average of 1 year
Objective Response Rate
Time Frame: Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2019

Primary Completion (Anticipated)

April 10, 2020

Study Completion (Anticipated)

April 10, 2021

Study Registration Dates

First Submitted

May 12, 2019

First Submitted That Met QC Criteria

May 16, 2019

First Posted (Actual)

May 20, 2019

Study Record Updates

Last Update Posted (Actual)

May 20, 2019

Last Update Submitted That Met QC Criteria

May 16, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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