CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 57 enrolled
Drug / intervention
Atezolizumab +6 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04941287
NCT04941287Phase 2Active

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

National Cancer Institute (NCI)·interventional·Posted Jun 28, 2021·Updated May 23, 2025

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

Phase 2ActiveOverdue
20222023202420252026
First PostedJun 28, 2021
Enrollment StartDec 15, 2021
Primary CompletionJan 2, 2024
Study CompletionApr 29, 2026
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 5.0 years ago

Interventions

Atezolizumabbiological

Given IV

Biopsyprocedure

Undergo tumor biopsy

Biospecimen Collectionprocedure

Undergo blood sample collection

Cobimetinibdrug

Given PO

Computed Tomographyprocedure

Undergo a CT scan

Magnetic Resonance Imagingprocedure

Undergo MRI

Varlilumabdrug

Given IV