CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 86 enrolled
Drug / intervention
Atezolizumab +5 moredrug
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/NCT03201458
NCT03201458Phase 2Completed

A Randomized Phase 2 Study of Atezolizumab in Combination With Cobimetinib Versus Atezolizumab Monotherapy in Participants With Unresectable Cholangiocarcinoma

National Cancer Institute (NCI)·interventional·Posted Jun 28, 2017·Updated Apr 5, 2024

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

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 28, 2017
Enrollment StartFeb 8, 2018
Primary CompletionAug 7, 2020
Study CompletionFeb 19, 2024
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9.0 years ago

Interventions

Atezolizumabdrug

Given IV

Biopsyprocedure

Undergo tumor biopsy

Biospecimen Collectionprocedure

Undergo collection of blood samples

Cobimetinibdrug

Given PO

Computed Tomographyprocedure

Undergo CT

Magnetic Resonance Imagingprocedure

Undergo MRI