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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: Completed Phase 2 study of Stage III Intrahepatic Cholangiocarcinoma AJCC v8 and Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS within each treatment arm will be summarized descriptively and compared between groups, under the assumption of Cox proportional hazards, using the stratified log-rank test to account for tumor site. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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 |
What the finished NCT03201458 record still lists
NCT03201458 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, above the 32-participant average among 8 other Stage III Intrahepatic Cholangiocarcinoma AJCC v8 trials with a reported enrollment target (169% higher).
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 names 20 study sites across 7 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03201458's enrollment target sits among peer trials
86 1st of 8 higher than 8 of 8 other Stage III Intrahepatic Cholangiocarcinoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Intrahepatic Cholangiocarcinoma AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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