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

NCT03394287 | Completed Phase 2 DMC

• 1 other identifier: SHR-1210-APTN-IIT-TNBC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• ORR

  Overall Response Rate

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

Secondary Outcomes (8)

• Incidence of Treatment-Emergent Adverse Events

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

• DCR

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

• DoR

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

• PFS

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

• One year-OS

  12 months after the first drug administration

Study Arms (2)

SHR-1210 +Apatinib daily dosing

EXPERIMENTAL

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

Drug: SHR-1210; Drug: Apatinib

SHR-1210+Apatinib intermittent dosing

EXPERIMENTAL

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)

Drug: SHR-1210; Drug: Apatinib

Interventions

SHR-1210 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.

SHR-1210 +Apatinib daily dosing; SHR-1210+Apatinib intermittent dosing

Apatinib DRUG

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

SHR-1210 +Apatinib daily dosing; SHR-1210+Apatinib intermittent dosing

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510120, China

Location

Related Publications (1)

• 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.

  PMID: 32448804 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

camrelizumab; apatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Erwei Song

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Sun Yat-sen Memorial Hospital

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 9, 2018
• Study Start: January 10, 2018
• Primary Completion: December 30, 2019
• Study Completion: September 30, 2020
• Last Updated: October 23, 2020

Record last verified: 2020-10

Locations

CN (1)