A Phase II Study of Pembrolizumab in Subjects with Triple-Negative Breast Cancer

Update Il y a 4 ans
Reference: EUCTR2015-000294-13

Woman and Man

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Extract

(1) Objective (Cohorts A+C): To evaluate the Overall Response Rate (ORR) to pembrolizumab as 2L+ monotherapy in subjects with PD-L1 strong (+) centrally confirmed mTNBC, based on RECIST 1.1 as assessed by the central imaging vendor. (2) Objective (Cohort A): To evaluate the ORR to pembrolizumab as 2L+ monotherapy for PD-L1 (+) centrally confirmed mTNBC, based on RECIST 1.1 as assessed by the central imaging vendor. (3) Objective (Cohort A): To evaluate the ORR to pembrolizumab as 2L+ monotherapy for centrally confirmed mTNBC independent of PD-L1 status (all comers), based on RECIST 1.1 as assessed by the central imaging vendor. (4) Objective (Cohorts A-C): To determine the safety and tolerability of pembrolizumab monotherapy for mTNBC across cohorts and by PD-L1 status within the line of treatment for mTNBC.


Inclusion criteria

  • Triple Negative Breast Cancer