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A Randomized Phase 2 Study of Cabozantinib in Combination with Nivolumab in Advanced, Recurrent Metastatic Endometrial Cancer
The purpose of this study is to compare any good and bad effects of using the drug cabozantinib along with the the drug nivolumab to using the drug nivolumab alone.
Primary Objectives: -To evaluate the clinical anti-tumor activity of XL184 (cabozantinib) and nivolumab based on progression free survival (PFS) in patients with advanced, recurrent ormetastatic endometrial cancer previously treated with at least one line of platinum-based chemotherapy compared to patients receiving nivolumab alone. Secondary Objectives: - To evaluate the efficacy of XL184 and nivolumab in terms of overall response rate (ORR) compared to nivolumab alone. - To evaluate overall survival (OS) of patients receiving XL184 and nivolumab compared to patients receiving nivolumab alone. - To evaluate the safety of combination treatment using XL184 and nivolumab in patients with advanced, recurrentmetastatic endometrial cancer. - To evaluate correlation between PD-L1 expression, CD3, CD4 and CD8 infiltrates and outcome (PFS, ORR, OS). - To compare PD-L1 expression, CD3, CD4 and CD8 infiltrates in the primary tumor (archival tissue) and in the tissue from baseline biopsy. - To assess activity (PFS, ORR and OS) of nivolumab alone or in combination with XL184 according to MSI/MMR status. Exploratory Objectives: - To assess activity (PFS, ORR and OS) of XL184 and nivolumab in patients progressed after previous exposure to anti PD-1, PD-L1 or PD-L2 agents or crossed-over from single agent nivolumab, and in patients with diagnosis of carcinosarcoma. - To compare MS and MMR status, in the primary tumor (archival tissue) and in the tissue from baseline biopsy. - To assess the genomic and immune-markers landscape at baseline on tumor tissue and changes in immune landscape in peripheral blood during treatment and correlate with outcome