At a glance
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A Randomized Phase 2 Study of Combination Atezolizumab and CDX-1127 (Varlilumab) With or Without Addition of Cobimetinib in Previously Treated Unresectable Biliary Tract Cancers
In Brief
A Phase 2 clinical trial evaluating Atezolizumab, Biopsy, and 5 other interventions for Metastatic Distal Bile Duct Adenocarcinoma and 9 related conditions. Active but no longer recruiting, targeting 57 participants across 29 sites.
Detailed Summary
This phase II trial investigates the effect of combining two immune therapies, atezolizumab and CDX-1127 (varlilumab), with or without cobimetinib, in treating patients with biliary tract cancer that cannot be removed by surgery (unresectable). 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. Varlilumab is an immune agonist antibody that may further strengthen the immune system's attack on the cancer. Cobimetinib 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 in combination with varlilumab and cobimetinib may work better than atezolizumab and varlilumab alone in treating patients with unresectable biliary tract cancer.
Study Details
Timeline
Interventions
Given IV
Undergo tumor biopsy
Undergo blood sample collection
Given PO
Undergo a CT scan
Undergo MRI
Given IV