Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UC Irvine
Dates
study started
completion around

Description

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.

Official Title

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

Details

Keywords

Metastatic Distal Bile Duct Adenocarcinoma, Metastatic Gallbladder Carcinoma, Metastatic Intrahepatic Cholangiocarcinoma, Recurrent Distal Bile Duct Adenocarcinoma, Recurrent Gallbladder Carcinoma, Recurrent Intrahepatic Cholangiocarcinoma, Stage IV Distal Bile Duct Cancer AJCC v8, Stage IV Gallbladder Cancer AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, Unresectable Liver Carcinoma, Carcinoma, Adenocarcinoma, Cholangiocarcinoma, Biliary Tract Neoplasms, Gallbladder Neoplasms, Bile Duct Neoplasms, Hepatocellular Carcinoma, Ductal Carcinoma, Recurrence, Atezolizumab, Immunoglobulins, Monoclonal Antibodies, Immunoglobulin G, Biopsy, Biospecimen Collection, Cobimetinib, Computed Tomography, Magnetic Resonance Imaging, Varlilumab, cobimetinib, atezolizumab, varlilumab, atezolizumab, varlilumab

Eligibility

Locations

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Cancer Institute (NCI)
ID
NCT04941287
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 56 people participating
Last Updated