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

Brief description of study

The purpose of the study is to evaluate the response rate of pembrolizumab in patients with evidence of genomic instability classified as follows: 1) All solid tumors with POLE and POLD1 mutations 2) All solid tumors with DNA repair mutations. We want to test if tumors with evidence of genomic instability such as those with mutations in POLE, POLD1 and BRCA1 and BRCA2 will have higher response rates than tumors that do not exhibit these mutations. The study drug pembrolizumab is investigational in this study, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial. Tumors with the following mutations can be included: RAD 51, PANCA or PANCC, ATM, ATR, PALB2 or other mutations that indicate DNA repair abnormalities.


Clinical Study Identifier: s20-01200
ClinicalTrials.gov Identifier: NCT03428802
Principal Investigator: Janice Mehnert.


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