Study on Pembrolizumab and Olaparib for People with Endometrial Cancer or Endometrial Carcinosarcoma
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT05156268
This clinical trial is exploring whether a combination of two drugs, pembrolizumab and olaparib, can effectively treat people with persistent or returning endometrial cancer or endometrial carcinosarcoma. The study will also assess the safety of this drug combination and monitor any side effects.
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Program Overview
The aim of this study is to determine if using pembrolizumab together with olaparib can help treat endometrial cancer or endometrial carcinosarcoma that has not gone away or has come back after treatment. Researchers will also check if this combination is safe and if it causes only mild or few side effects in participants.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of persistent or returning endometrial cancer, including specific types like serous endometrial cancer or carcinosarcoma.
- Have had one to three previous treatments for endometrial cancer, including chemotherapy.
- Have measurable cancer that can be tracked using standard criteria.
- Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate blood and organ function as shown by specific lab tests.
- Be 18 years or older.
- Women must not be pregnant or breastfeeding and must agree to use effective contraception if of childbearing potential.
- HIV-positive patients can participate if they are on effective treatment with an undetectable viral load.
- Have no other cancers that could interfere with the study.
- Agree to provide written informed consent for participation.
Exclusion Criteria
- Have previously received certain types of cancer treatments, including specific immunotherapy or PARP inhibitors.
- Have participated in another cancer study and received treatment within the last four weeks.
- Have received radiation therapy within two weeks before starting the study.
- Have received a live vaccine within 30 days before starting the study.
- Have an immune system deficiency or are taking high doses of steroids or other immune-suppressing drugs.
- Have untreated or unstable brain metastases.
- Have severe allergies to pembrolizumab or olaparib.
- Have active autoimmune diseases requiring treatment in the past two years.
- Have a history of lung inflammation requiring steroids.
- Have uncontrolled illnesses, such as severe infections or heart problems.
- Have significant liver disease or active hepatitis.
- Cannot swallow pills or have digestive issues affecting medication absorption.
- Have blood disorders like myelodysplastic syndrome or acute myeloid leukemia.
- Are taking certain medications that interact with the study drugs and cannot stop them for the study duration.
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