Pembrolizumab + Olaparib for Endometrial Cancer
Trial Summary
What is the purpose of this trial?
The purpose of this study is to find out whether the combination of pembrolizumab and olaparib is an effective treatment for people with persistent or recurrent endometrial cancer or endometrial carcinosarcoma. The researchers will also look at the safety of the drug combination and whether it causes few or mild side effects in participants.
Will I have to stop taking my current medications?
The trial requires that you stop any hormonal therapy for endometrial cancer at least one week before starting. If you are taking strong or moderate inhibitors or inducers of CYP3A4, you will need to stop them for a washout period of 2 to 5 weeks before starting the study. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
What data supports the effectiveness of the drugs Pembrolizumab and Olaparib for treating endometrial cancer?
Pembrolizumab has shown a meaningful response rate in patients with advanced endometrial cancer that has specific genetic features (MSI-H/dMMR), as seen in the KEYNOTE-158 study. Additionally, a case report showed that a combination of Olaparib and Pembrolizumab, along with another drug, was effective in treating a different type of cancer, suggesting potential benefits of this combination.12345
Is the combination of Pembrolizumab and Olaparib safe for humans?
Olaparib (Lynparza) has been studied for safety in various cancers, including ovarian and breast cancer, and is generally considered safe when used as a single agent or in combination with other treatments. Pembrolizumab (KEYTRUDA) is also widely used and has a known safety profile. However, specific safety data for the combination of Pembrolizumab and Olaparib in endometrial cancer is not provided in the available research.56789
How is the drug combination of Pembrolizumab and Olaparib unique for treating endometrial cancer?
This drug combination is unique because Pembrolizumab, an immunotherapy drug, is used to enhance the body's immune response against cancer cells, while Olaparib, a PARP inhibitor, targets cancer cell DNA repair mechanisms. This combination may offer a novel approach for patients with advanced endometrial cancer, especially those with specific genetic markers like microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), where traditional treatments may not be effective.1231011
Research Team
Maria Rubinstein, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Eligibility Criteria
This trial is for adults with certain types of endometrial cancer who've had no more than three prior treatments (excluding hormonal therapy). They must have measurable disease, be in good physical condition, and not be pregnant or breastfeeding. People with severe allergies to the drugs being tested, active autoimmune diseases, recent immunosuppressive therapies, or uncontrolled illnesses cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive olaparib orally at 300 mg every 12 hours and pembrolizumab intravenously at 200 mg every 3 weeks
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?
Memorial Sloan Kettering Cancer Center
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