Olaparib + Pembrolizumab for Breast Cancer
Trial Summary
What is the purpose of this trial?
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 is superior to chemotherapy plus pembrolizumab with respect to progression-free survival (PFS). 2. Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to overall survival (OS). As of Amendment 3, study enrollment was discontinued. Participants who were receiving benefit from the study intervention could continue treatment until criteria for discontinuation are met. Participants who are on study treatment or in follow-up phase will no longer have tumor response assessments by BICR.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are taking certain medications that interact with the study drugs, like strong or moderate inhibitors or inducers of CYP3A4, unless they can be stopped before the study.
What data supports the effectiveness of the drug combination Olaparib and Pembrolizumab for breast cancer?
Research shows that Olaparib, a part of this drug combination, significantly improves progression-free survival in patients with certain types of breast cancer, particularly those with BRCA mutations. It has been effective in extending the time patients live without their cancer getting worse compared to standard chemotherapy.12345
Is the combination of Olaparib and Pembrolizumab safe for humans?
How is the drug combination of Olaparib and Pembrolizumab unique for breast cancer treatment?
The combination of Olaparib and Pembrolizumab is unique because it combines a PARP inhibitor (Olaparib) that targets cancer cells with BRCA mutations and an immune checkpoint inhibitor (Pembrolizumab) that helps the immune system attack cancer cells, offering a novel approach for treating certain types of breast cancer.15789
Research Team
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Eligibility Criteria
This trial is for adults with triple negative breast cancer (TNBC) that's either inoperable and not previously treated with chemotherapy, or metastatic without prior chemo. Participants should have a life expectancy of at least 27 weeks, be in good physical condition (ECOG status of 0 or 1), have adequate organ function, and agree to use contraception. Pregnant or breastfeeding women, those with certain other cancers or conditions like active CNS metastases, autoimmune diseases requiring recent treatment, severe infections including HIV/Hepatitis B/C, heart failure within the past six months, uncontrolled illnesses that could affect study participation are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Participants receive first-line chemotherapy plus pembrolizumab
Post-Induction Treatment
Participants receive either olaparib plus pembrolizumab or chemotherapy plus pembrolizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Carboplatin
- Gemcitabine
- 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?
Merck Sharp & Dohme Corp.
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme Corp.
Chief Medical Officer
Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme Corp.
Chief Executive Officer since 2021
J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Merck Sharp & Dohme LLC
Lead 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