Olaparib + Pembrolizumab for Advanced Cancer
Trial Summary
What is the purpose of this trial?
The purpose of this study is to assess the efficacy and safety of treatment with olaparib (MK-7339) in combination with pembrolizumab (MK-3475) in adults with previously treated, advanced (metastatic and/or unresectable) Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-positive solid tumors.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications that affect the liver enzyme CYP3A4. If you are on strong or moderate inhibitors or inducers of CYP3A4, you will need to stop them for a specific period before starting the trial: 2 weeks for inhibitors and up to 5 weeks for inducers like phenobarbital.
What data supports the effectiveness of the drug combination Olaparib and Pembrolizumab for advanced cancer?
Research shows that Pembrolizumab and Olaparib, when used together, have shown activity in treating metastatic castration-resistant prostate cancer, a type of advanced cancer. Additionally, Pembrolizumab has been effective in improving survival in patients with advanced non-small-cell lung cancer when used with other treatments.12345
Is the combination of Olaparib and Pembrolizumab safe for humans?
Olaparib (also known as Lynparza) has been tested in various studies for conditions like ovarian and breast cancer, showing it can be used safely in humans. While specific safety data for the combination with Pembrolizumab (KEYTRUDA) isn't provided, Olaparib alone has been administered safely in clinical trials.678910
How is the drug combination of Olaparib and Pembrolizumab unique for treating advanced cancer?
The combination of Olaparib and Pembrolizumab is unique because it combines a PARP inhibitor (Olaparib) that targets cancer cells with DNA repair issues, often seen in BRCA mutations, with an immunotherapy drug (Pembrolizumab) that helps the immune system recognize and attack cancer cells. This dual approach may offer a novel way to treat advanced cancers by addressing both genetic vulnerabilities and enhancing immune response.6791112
Research Team
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Eligibility Criteria
Adults with advanced solid tumors that have specific genetic mutations or deficiencies, who've had some response to platinum-based therapies and are not eligible for curative treatment. They must be in relatively good health, agree to contraception, and not be pregnant or breastfeeding. Exclusions include certain blood disorders, active infections or autoimmune diseases, recent treatments with other cancer drugs or vaccines, and known allergies to trial medications.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive olaparib 300 mg via oral tablet 2 times each day plus pembrolizumab 200 mg via intravenous infusion on Day 1 of each 21-day cycle. Treatment may continue for up to approximately 2 years.
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?
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