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NCT03201458 · ClinicalTrials.gov registry record · Phase 2
Atezolizumab With or Without Cobimetinib in Treating Patients With Metastatic Bile Duct Cancer That Cannot Be Removed by Surgery or Gallbladder Cancer
A Phase 2 study of Stage III Intrahepatic Cholangiocarcinoma AJCC v8 and Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 86
- Enrollment target
- 20
- Study locations
NCT03201458 is a Phase 2 study of Stage III Intrahepatic Cholangiocarcinoma AJCC v8 and Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 86 participants, above the 32-participant average among 8 other Stage III Intrahepatic Cholangiocarcinoma AJCC v8 trials with a reported enrollment target (169% higher). The trial reports 20 study locations across 7 states.
The verdict
NCT03201458, a Phase 2 study of Stage III Intrahepatic Cholangiocarcinoma AJCC v8 and Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 86 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Atezolizumab
- PROCEDURE Biopsy
- DRUG Cobimetinib
Study Locations (20)
Connecticut
- Smilow Cancer Hospital-Derby Care Center - Derby
- Smilow Cancer Hospital Care Center-Fairfield - Fairfield
- Smilow Cancer Hospital Care Center - Guilford - Guilford
- Smilow Cancer Hospital Care Center at Saint Francis - Hartford
- Smilow Cancer Center/Yale-New Haven Hospital - New Haven
- Yale University - New Haven
- Yale-New Haven Hospital North Haven Medical Center - North Haven
- Smilow Cancer Hospital-Torrington Care Center - Torrington
- Smilow Cancer Hospital Care Center-Trumbull - Trumbull
- Smilow Cancer Hospital-Waterbury Care Center - Waterbury
California
- City of Hope Comprehensive Cancer Center - Duarte
- University of California Davis Comprehensive Cancer Center - Sacramento
- City of Hope South Pasadena - South Pasadena
Florida
- University of Florida Health Science Center - Gainesville - Gainesville
- Moffitt Cancer Center - Tampa
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
Colorado
- UCHealth University of Colorado Hospital - Aurora
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2018-02-08 |
| Est. Completion | 2024-02-19 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03201458
The ClinicalTrials.gov registry entry for NCT03201458 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 32-participant average among 8 other Stage III Intrahepatic Cholangiocarcinoma AJCC v8 trials with a reported enrollment target (169% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Stage III Intrahepatic Cholangiocarcinoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT03201458 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Connecticut, California, Florida.
Frequently Asked Questions
What is clinical trial NCT03201458 about?
NCT03201458 is a clinical study titled "Atezolizumab With or Without Cobimetinib in Treating Patients With Metastatic Bile Duct Cancer That Cannot Be Removed by Surgery or Gallbladder Cancer". 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 anti...
What is the current status of trial NCT03201458?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2018-02-08. Estimated completion is 2024-02-19.
What conditions does trial NCT03201458 study?
This clinical trial studies the following conditions: Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, Metastatic Cholangiocarcinoma, Gallbladder Carcinoma, Unresectable Cholangiocarcinoma.
What interventions are being tested in trial NCT03201458?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Atezolizumab (DRUG), Biopsy (PROCEDURE), Cobimetinib (DRUG).
Who is sponsoring clinical trial NCT03201458?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03201458 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.