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A Randomized Phase 2 Study of Atezolizumab in Combination with Cobimetinib versus Atezolizumab Monotherapy in Participants with resectable Cholangiocarcinoma
This randomized phase II trial studies how well atezolizumab with or without cobimetinib works in treating patients with bile duct cancer that has spread to other places in the body and cannot be removed by surgery or gallbladder cancer. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab with cobimetinib may work better at treating patients with bile duct and gallbladder cancer.
1.1 Primary Objectives: 1.1.1 To assess the progression free survival (PFS) of patients receiving atezolizumab monotherapy and cobimetinib in combination with atezolizumab for unresectable cholangiocarcinoma. 1.2 Secondary Objectives: 1.2.1 To assess the overall survival (OS) of patients receiving cobimetinib in combination with atezolizumab and atezolizumab monotherapy for unresectable cholangiocarcinoma. 1.2.2 To determine the objective response rate (ORR), defined as complete plus partial response, of cobimetinib in combination with atezolizumab and atezolizumab monotherapy in patients with unresectable cholangiocarcinoma. 1.2.3 To assess the safety and tolerability of cobimetinib in combination with atezolizumab and atezolizumab monotherapy in patients with unresectable cholangiocarcinoma. 1.2.4 To determine the relationship between PD-L1 expression in tumor at baseline and on treatment, and response to treatment. 1.3 Correlative Objectives: 1.3.1 To determine the effect of cobimetinib on CD8+ T cell infiltration in tumor. 1.3.2 To determine the effect of cobimetinib on T cell subpopulations systemically and in tumor, PD-1/PD-L1 expression on tumor, and MHC 1/2 expression. 1.3.3 To determine the effect of cobimetinib on markers of immune exhaustion and proapoptotic factors in CD8+ effector T cells. 1.3.4 To explore the effect of cobimetinib on local and systemic immune activation pathways and immune suppressive pathways through expression profiling.