Femme et Homme
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Extrait
Part 1 (Safety Run-In): Objective: To evaluate the safety and tolerability of 3 pembrolizumab + chemotherapy combinations, namely, pembrolizumab + paclitaxel, pembrolizumab + nab paclitaxel, and pembrolizumab + gemcitabine/carboplatin. Part 2 (Phase III study): Objective: To compare progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by a blinded central imaging vendor (CIV) in all subjects. Objective: To compare PFS based on RECIST 1.1 as assessed by a blinded CIV in subjects with programmed cell death ligand 1 (PD-L1) positive tumors. Objective: To compare overall survival (OS) in all subjects. Objective: To compare OS in subjects with PD-L1 positive tumors.
Critère d'inclusion
- Triple Negative Breast Cancer