drugset / Trial / NCT05033756
Comprehensive Analysis of Predictors of the Treatment With Pembrolizumab and Olaparib in Patients With Unresectable or Metastatic HER2 Negative Breast Cancer and a Deleterious Germline Mutation or a Homologous Recombination Deficiency (COMPRENDO
Phase 2
Active not recruiting
11 enrolled
Institut fuer Frauengesundheit
Merck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment
Summary
This study will examine the combination of pembrolizumab and olaparib in three populations. * Cohort 1: aBC patients with a germline mutation in BRCA1 or BRCA2, * cohort 2: aBC patients with a germline mutation in one of the moderate penetrance homologous repair genes (ATM, BARD1, CHEK2, FANCC, PALB2, RAD51C, RAD51D, SLX4, XRCC2), and * cohort 3: aBC patients with a HRD as assessed by whole genome sequencing.
Timeline
- Start
- 2022-07-30
- Primary completion
- 2025-01
- Completion
- 2026-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olaparib | Small molecule | 300 mg | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |