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RecruitingPhase 2NCT03428802

Pembrolizumab in Treating Participants With Metastatic, Recurrent or Locally Advanced Cancer and Genomic Instability

A Basket Trial of Pembrolizumab in Patients With Advanced Solid Tumors and Genomic Instability

Sponsor

Rutgers, The State University of New Jersey

Enrollment

40 participants

Start Date

Mar 8, 2018

Study Type

INTERVENTIONAL

Conditions

Metastatic Malignant Solid NeoplasmRecurrent Ovarian CarcinomaStage III Ovarian Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage III Breast Cancer AJCC v7Stage IV Breast Cancer AJCC v6 and v7Stage IIIA Ovarian Cancer AJCC v8Stage IIIB Ovarian Cancer AJCC v8Stage IIIC Ovarian Cancer AJCC v8Recurrent Malignant Solid NeoplasmStage IVA Ovarian Cancer AJCC v8Stage IVB Ovarian Cancer AJCC v8BRCA1 Gene MutationBRCA2 Gene MutationLocally Advanced Solid NeoplasmPOLD1 Gene MutationPOLE Gene MutationStage IIIA Breast Cancer AJCC v7Stage IIIB Breast Cancer AJCC v7Stage IIIC Breast Cancer AJCC v7

Summary

This phase II trial studies how well pembrolizumab works in treating participants with cancer that has spread to other places in the body, has come back or has spread to nearby tissues or lymph nodes. Monoclonal antibodies such as, pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing the immunotherapy drug pembrolizumab (Keytruda) in patients whose cancers have specific genetic mutations (in POLE, POLD1, BRCA1, or BRCA2 genes) that may make the tumor more vulnerable to immune-based treatments. **You may be eligible if...** - You have advanced, metastatic, or recurrent cancer that can be measured on scans - Your tumor has been tested and shows mutations in POLE or POLD1 (arm 1) or BRCA1/BRCA2 (arm 2) on a certified genetic test - You are willing to undergo a tumor biopsy - You are in adequate overall health **You may NOT be eligible if...** - You have had prior treatment with pembrolizumab or similar immune checkpoint drugs - You have active autoimmune disease or are on systemic steroids - You have untreated brain metastases - You are pregnant or breastfeeding - You have HIV, active hepatitis B or C Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERLaboratory Biomarker Analysis

Correlative studies

BIOLOGICALPembrolizumab

Given IV

Locations(2)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States

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NCT03428802

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