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A Phase 1-2 Study of the Combination of Olaparib and Tremelimumab in BRCA1 and BRCA2 Mutation Carriers with Recurrent Ovarian Cancer
The purpose of this study is to evaluate the safety and efficacy of a combination of a PARP inhibitor (Olaparib) with a T cell checkpoint inhibitor (the anti-CTLA-4 antibody Tremelimumab) in women with recurrent BRCA mutation-associated ovarian cancer.
1.0 STUDY OBJECTIVES 1.1 Primary Objectives: Phase 1 Component Primary Objective: To define the safety profile of Tremelimumab and Olaparib in women with BRCA1 or BRCA2 mutation-associated ovarian, tubal, or primary peritoneal cancer who are refractory to standard therapy. Phase 2 Component Primary Objective: To determine the preliminary efficacy of the combination of Tremelimumab and Olaparib as measured by objective response (partial plus complete remission) according to the new immune-related response criteria in solid tumors (irRC). 2.2 Secondary Objectives Phase 2 Component: -To determine overall survival (OS), and progression free survival (PFS) according to the new immune-related response criteria in solid tumors (irRC). -To determine the adverse event profile and tolerability of the combination of Tremelimumab and Olaparib in patients with BRCA1 or BRCA2 mutation-associated ovarian cancer. 2.3 Translational Objectives: -To evaluate immunologic correlates of response to combination therapy (absolute lymphocyte count, myeloid derived suppressor cell numbers, T cell subsets, T cell function and specificity) in both peripheral blood and tumor (when possible). -To identify biomarkers of response to combined targeted and immune therapy through genomic analysis and cytokine profiling of peripheral blood samples. -To explore whether resistance mechanisms to PARP-inhibitors can be overcome with the addition of immune checkpoint blockade. -The exploratory analyses may not be reported in the clinical study report (CSR), if not, they will be reported separately.