Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK-009)

• Status: Active, not recruiting
• Trial end date: 2026-01-26

Summary

The purpose of this study is to compare the efficacy of olaparib (MK-7339) plus pembrolizumab (MK-3475) with chemotherapy plus pembrolizumab after induction with first-line chemotherapy plus pembrolizumab in triple negative breast cancer (TNBC). The primary hypotheses are:

1. Olaparib plus pembrolizumab prolongs progression-free survival (PFS) compared with chemotherapy plus pembrolizumab.

2. Olaparib plus pembrolizumab is non-inferior to chemotherapy plus pembrolizumab in terms of overall survival (OS).

3. Olaparib plus pembrolizumab prolongs OS compared with chemotherapy plus pembrolizumab.

• Phase: Phase 2/Phase 3

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Carboplatin; Gemcitabine; Olaparib; Pembrolizumab