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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03394287
• Other study ID #: SHR-1210-APTN-IIT-TNBC
• Status: Completed
• Phase: Phase 2
• Start date: January 10, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2020
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

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