This randomized, open-label phase 3 study will evaluate the safety and efficacy of Carelizumab (an engineered anti-programmed death-ligand 1 \[PD-1\] antibody) in combination with Nab-paclitaxel and Apatinib, carelizumab plus nab-paclitaxel, and Nab-paclitaxel in Patients with Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer. Participants will be randomized in a 1:1:1 ratio to Arm A (Carelizumab + Nab-paclitaxel + Apatinib), Arm B (Carelizumab + Nab-paclitaxel), or Arm C (Nab-paclitaxel).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Participants receive SHR-1210 intravenously (IV)
administered intravenously every 4-week cycle
administered orally every 4-week cycle
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Progression-free Survival (PFS)
Progression-free survival (PFS) as determined by the IRC according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in PD-L1 positive / ITT population
Time frame: Randomisation to the first occurrence of disease progression or death (through the end of study, approximately 42 months)
Progression Free Survival (PFS)
Progression Free Survival (PFS) as determined by the investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in PD-L1 positive/ITT population
Time frame: Up to approximately 42 months
Overall Survival (OS) in PD-L1 positive/ITT population
Time frame: Up to approximately 42 months
Objective response rate (ORR) in the PD-L1-positive/ITT population
Time frame: Up to approximately 42 months
Clinical benefit rate (CBR), defined as the proportion of patients with a CR or a PR or stable disease as determined by the investigator according to RECIST 1.1
Time frame: Up to approximately 42 months
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to approximately 42 months
Serum concentration of SHR-1210 and plasma concentration of apatinib
Time frame: Up to approximately 42 months
Proportion of anti-SHR-1210 antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline
Time frame: Up to approximately 42 months
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