Study on Olaparib and Pembrolizumab for Treating Advanced Cancers with Specific Genetic Mutations
Sponsor: Merck Sharp & Dohme LLC
Sponsor score: 40
Inactive
ClinicalTrials ID:NCT04123366
This clinical trial is testing a combination of two drugs, olaparib and pembrolizumab, to see if they are safe and effective in treating adults with advanced cancers that have specific genetic mutations affecting DNA repair.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the effectiveness and safety of using olaparib together with pembrolizumab in adults who have advanced cancers with specific genetic mutations related to DNA repair. These cancers have not responded to standard treatments or cannot be surgically removed.
Eligibility Criteria
Inclusion Criteria
- Have an advanced solid tumor (except breast or ovarian cancer with BRCA mutation) that cannot be cured and has not responded to standard treatments.
- Have specific genetic mutations related to DNA repair, confirmed by a special test.
- Have measurable cancer that can be tracked using standard criteria.
- Have a life expectancy of at least 3 months.
- Have responded to previous platinum-based chemotherapy.
- Be in good overall health with a performance status of 0 or 1.
- Male participants must agree to use contraception during treatment and for 3 months after the last dose of olaparib.
- Female participants must not be pregnant or breastfeeding and must agree to use contraception during treatment and for 4 months after the last dose of pembrolizumab and 6 months after the last dose of olaparib.
- Have adequate organ function.
Exclusion Criteria
- Have another progressing cancer or one that required treatment in the last 3 years, except for certain skin or cervical cancers.
- Have a history of lung diseases requiring steroids or currently have lung disease.
- Have blood disorders like myelodysplastic syndrome or acute myeloid leukemia.
- Have cancer that has spread to the brain or spinal cord.
- Have an active infection requiring treatment.
- Have active tuberculosis.
- Have an immune deficiency or are on high-dose steroids or other immune-suppressing drugs.
- Have an active autoimmune disease needing treatment in the past 2 years.
- Have received certain growth factors within 28 days before starting the study.
- Have HIV, active hepatitis B, or hepatitis C.
- Cannot swallow pills or have digestive issues affecting absorption.
- Have had previous treatments with similar drugs or certain cancer therapies recently.
- Have allergies to the study drugs or their ingredients.
- Are taking certain medications that affect how the study drugs work and cannot stop them.
- Have had a bone marrow or cord blood transplant.
- Have had a blood transfusion recently.
- Have had recent radiation therapy or are in another clinical trial.
- Have heart conditions that are not controlled.
- Have had major surgery recently or have not recovered from surgery.
- Have received a live vaccine recently.
- Have had an organ transplant.
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