At a glance
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A Randomized Phase 2 Study of Atezolizumab in Combination With Cobimetinib Versus Atezolizumab Monotherapy in Participants With Unresectable Cholangiocarcinoma
In Brief
A Phase 2 clinical trial evaluating Atezolizumab, Biopsy, and 4 other interventions for Gallbladder Carcinoma and 4 related conditions. Completed, enrolled 86 participants across 41 sites.
Detailed Summary
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 (metastatic) and cannot be removed by surgery (unresectable) or gallbladder cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cobimetinib is used in patients whose cancer has a mutated (changed) form of a gene called BRAF. It is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving atezolizumab with cobimetinib may work better at treating patients with bile duct and gallbladder cancer.
Study Details
Timeline
Interventions
Given IV
Undergo tumor biopsy
Undergo collection of blood samples
Given PO
Undergo CT
Undergo MRI