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

NCT ID: NCT03394287

Last Updated: 2020-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-10
• Study Completion Date: 2020-09-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

SHR-1210

Intervention Type: DRUG

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

Intervention Type: DRUG

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

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)

Group Type: EXPERIMENTAL

SHR-1210

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Interventions

SHR-1210

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

Apatinib

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Erwei Song, M.D., Ph.D.

President of Sun Yat-sen Memorial Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erwei Song

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 32448804 (View on PubMed)

Other Identifiers

SHR-1210-APTN-IIT-TNBC

Identifier Type: -

Identifier Source: org_study_id