A Trial of SHR-1210 (an Anti-PD-1 Antibody) in Combination With Apatinib in Patients With Advanced TNBC

October 21, 2020 updated by: Erwei Song, M.D., Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

A Phase II, Open-labeled, Randomised, Non-comparative, Two-arms Investigator-initiated Clinical Trial of SHR-1210 (Anti-PD-1 Antibody) in Combination With Apatinib in Subjects With Advanced Triple Negative Breast Cancer

This is a Phase II, Open-labeled, Randomised, Parallel, Non-comparative, Two-arms, Investigator-initiated Clinical Trial of SHR-1210 (Anti-PD-1 Antibody) in Combination With Apatinib (VEGFR2 inhibitor) in Subjects with Advanced Triple Negative Breast Cancer. Subjects with advanced Triple Negative Breast Cancer will be recruited. Patients will be randomised to two treatment arms of this study. One arm is SHR-1210 combination with apatinib daily dosing, and the other arm is SHR-1210 combination with apatinib intermittent dosing; each arm will enrolle10-29 subjects (Simons two stage design).

This study aims to evaluate the efficacy and safety of SHR-1210 combination with apatinib in the treatment of advanced TNBC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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

    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • The patients signed the written informed consent
  • Women aged 18-70.
  • The pathologic diagnosis of recurrent metastatic triple negative breast cancer [ER-negative(IHC<1%), PR-negative(IHC<1%), HER2-negative(IHC-/+ or IHC++ and FISH/CISH-)].
  • At least one measuring lesion that conforms to RECIST v1.1 standard.
  • The number of chemotherapy lines in the metastatic phase was <3 line.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
  • Have a life expectancy of at least 12 weeks.
  • Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment.
  • The patients can swallow pills.
  • The results of patients' blood tests are as follows: • Hb≥90g/L; • Plt≥90E+9/L; • Neutrophils≥1.5E+9/L; • ALT and AST ≤ triple of normal upper limit; • TBIL ≤ 1.5 times of normal upper limit; • Creatinine ≤ 1.5 times of normal upper limit.

Exclusion Criteria:

  • The subjects had any history of autoimmune disease or any use of systemic glucocorticoid or immunosuppressive medications.
  • Subjects with severe allergic reactions to other monoclonal antibodies.
  • The subjects had a central nervous system metastases with clinical symptoms.
  • History of hypertension and antihypertensive medications are not well controlled.
  • A heart condition or disease that is not well controlled.
  • Subjects had active infections or recent treatment with a systemic immunostimulatory agent (received within the previous 4 weeks).
  • Other clinical trials of drugs were used in the first four weeks of the first medication.
  • Subjects with treatment history of anti-angiogenesis drugs or check-point inhibitors.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR-1210 +Apatinib daily dosing
SHR-1210 200mg(3mg/kg for patient whose weight is below 50kg) iv Q2W combination With Apatinib 250mg, po, daily dosing (d1-d14)
SHR-1210 200mg (3mg/kg for patient whose weight is below 50kg) will be administered as an intravenous infusion over 30 minutes every two weeks until unacceptable toxic effects or disease progression or other termination criteria appeared.
Apatinib 250mg will be taked daily/intermittent dosing until unacceptable toxic effects or disease progression or other termination criteria appeared.
Experimental: SHR-1210+Apatinib intermittent dosing
SHR-1210 200mg (3mg/kg for patient whose weight is below 50kg) iv Q2W combination With Apatinib 250mg, po, intermittent dosing(Continuous administration for 7 days every 14 days, d1-d7)
SHR-1210 200mg (3mg/kg for patient whose weight is below 50kg) will be administered as an intravenous infusion over 30 minutes every two weeks until unacceptable toxic effects or disease progression or other termination criteria appeared.
Apatinib 250mg will be taked daily/intermittent dosing until unacceptable toxic effects or disease progression or other termination criteria appeared.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months)
Overall Response Rate
from the first drug administration up to the first occurrence of progression or death(up to 24 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TTR
Time Frame: from the first drug administration up to one year
Time to response
from the first drug administration up to one year
Incidence of Treatment-Emergent Adverse Events
Time Frame: from the first drug administration to within 90 days for the last SHR-1210 dose
adverse events/serious adverse events
from the first drug administration to within 90 days for the last SHR-1210 dose
DCR
Time Frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months)
Disease Control Rate
from the first drug administration up to the first occurrence of progression or death(up to 24 months)
DoR
Time Frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months)
Duration of response
from the first drug administration up to the first occurrence of progression or death(up to 24 months)
PFS
Time Frame: from the first drug administration up to the first occurrence of progression or death (up to about 5 years)
Progression-Free-Survival
from the first drug administration up to the first occurrence of progression or death (up to about 5 years)
One year-OS
Time Frame: 12 months after the first drug administration
One year-Overall survival
12 months after the first drug administration
CBR
Time Frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months)
Clinical benefit rate
from the first drug administration up to the first occurrence of progression or death(up to 24 months)
Frequencies Of Biomarkers
Time Frame: pre-dose, and up to two years
Biomarkers (PD-L1, PD-1, VEGF-A, eg) in tumor tissue and peripheral blood
pre-dose, and up to two years

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Erwei Song, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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)

January 10, 2018

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

January 2, 2018

First Submitted That Met QC Criteria

January 6, 2018

First Posted (Actual)

January 9, 2018

Study Record Updates

Last Update Posted (Actual)

October 23, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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