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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

NCT05033756 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2024-05-07

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Pembrolizumab Injection [Keytruda]

The planned dose of pembrolizumab for this study is 200 mg every 3 weeks (Q3W). Based on the totality of data generated in the Keytruda development program, 200 mg Q3W is the appropriate dose of pembrolizumab for adults across all indications and regardless of tumor type.

DRUG

Olaparib Oral Tablet [Lynparza]

All patients will receive olaparib treatment as an addition to pembrolizumab. The dose of olaparib used in this study is 300 mg twice daily (total daily dose of 600 mg) which is the currently approved dose.

Sponsors & Collaborators

Principal Investigators

  • Peter A. Fasching, MD, Prof. · Department of Gynecology and Obstetrics, Erlangen University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-30
Primary Completion
2025-01-31
Completion
2026-02-28
FDA Drug
Yes

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05033756 on ClinicalTrials.gov