Pembrolizumab + Olaparib for Breast Cancer
Trial Summary
What is the purpose of this trial?
This trial will evaluate the use of immunotherapy and PARP inhibition in a population with incurable advanced breast cancer associated with a germline BRCA mutation or HDR-defect. The main objective is to examine overall response rate of pembrolizumab (immunotherapy) in combination with Olaparib (PARP inhibitor) in advanced BRCA-mutated or Homology-directed repair (HDR)-defect breast cancer.
Research Team
Yuan Yuan, MD PhD
Principal Investigator
Cedars-Sinal Medical Center
Eligibility Criteria
This trial is for adults with advanced breast cancer that's linked to a BRCA mutation or HDR-defect. Participants must have measurable disease, adequate organ function, and a life expectancy of at least 16 weeks. Women should be postmenopausal or use two forms of contraception; men must use condoms. Exclusions include recent other treatments, additional cancers needing treatment, inability to take oral meds, certain infections like HIV/Hepatitis B/C, active autoimmune diseases, and known allergies to the drugs tested.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab in combination with Olaparib for advanced BRCA-mutated or HDR-defect breast cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Olaparib
- Pembrolizumab
Olaparib is already approved in European Union, United States for the following indications:
- Breast cancer
- Ovarian cancer
- Fallopian tube cancer
- Peritoneal cancer
- Pancreatic cancer
- Prostate cancer
- Endometrial cancer
- Ovarian, fallopian tube, and primary peritoneal cancer
- Breast cancer
- Prostate cancer
- Pancreatic cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yuan Yuan
Lead Sponsor
Monica Mita
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University