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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

SHR-1210

Apatinib

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

SHR-1210 +Apatinib daily dosing

SHR-1210+Apatinib intermittent dosing

Arm Description

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) iv Q2W combination With Apatinib 250mg, po, intermittent dosing(Continuous administration for 7 days every 14 days, d1-d7)

Outcomes

Primary Outcome Measures

ORR

Overall Response Rate

Secondary Outcome Measures

Incidence of Treatment-Emergent Adverse Events

adverse events/serious adverse events

DCR

Disease Control Rate

DoR

Duration of response

PFS

Progression-Free-Survival

One year-OS

One year-Overall survival

CBR

Clinical benefit rate

TTR

Time to response

Frequencies Of Biomarkers

Biomarkers (PD-L1, PD-1, VEGF-A, eg) in tumor tissue and peripheral blood

Full Information

NCT ID

NCT03394287

First Posted

January 2, 2018

Last Updated

October 21, 2020

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

1. Study Identification

Unique Protocol Identification Number

NCT03394287

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

January 10, 2018 (Actual)

Primary Completion Date

December 30, 2019 (Actual)

Study Completion Date

September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SHR-1210 +Apatinib daily dosing

Arm Type

Experimental

Arm Description

SHR-1210 200mg(3mg/kg for patient whose weight is below 50kg) iv Q2W combination With Apatinib 250mg, po, daily dosing (d1-d14)

Arm Title

SHR-1210+Apatinib intermittent dosing

Arm Type

Experimental

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

SHR-1210

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Apatinib

Intervention Description

Apatinib 250mg will be taked daily/intermittent dosing until unacceptable toxic effects or disease progression or other termination criteria appeared.

Primary Outcome Measure Information:

Title

ORR

Description

Overall Response Rate

Time Frame

from the first drug administration up to the first occurrence of progression or death(up to 24 months)

Secondary Outcome Measure Information:

Title

Incidence of Treatment-Emergent Adverse Events

Description

adverse events/serious adverse events

Time Frame

from the first drug administration to within 90 days for the last SHR-1210 dose

Title

DCR

Description

Disease Control Rate

Time Frame

from the first drug administration up to the first occurrence of progression or death(up to 24 months)

Title

DoR

Description

Duration of response

Time Frame

from the first drug administration up to the first occurrence of progression or death(up to 24 months)

Title

PFS

Description

Progression-Free-Survival

Time Frame

from the first drug administration up to the first occurrence of progression or death (up to about 5 years)

Title

One year-OS

Description

One year-Overall survival

Time Frame

12 months after the first drug administration

Title

CBR

Description

Clinical benefit rate

Time Frame

from the first drug administration up to the first occurrence of progression or death(up to 24 months)

Title

TTR

Description

Time to response

Time Frame

from the first drug administration up to one year

Title

Frequencies Of Biomarkers

Description

Biomarkers (PD-L1, PD-1, VEGF-A, eg) in tumor tissue and peripheral blood

Time Frame

pre-dose, and up to two years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erwei Song

Organizational Affiliation

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32448804

Citation

Liu J, Liu Q, Li Y, Li Q, Su F, Yao H, Su S, Wang Q, Jin L, Wang Y, Lau WY, Jiang Z, Song E. Efficacy and safety of camrelizumab combined with apatinib in advanced triple-negative breast cancer: an open-label phase II trial. J Immunother Cancer. 2020 May;8(1):e000696. doi: 10.1136/jitc-2020-000696.

Results Reference

derived

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

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