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NCT04941287 · ClinicalTrials.gov registry record · Phase 2
Testing A New Combination of Anti-cancer Immune Therapies, Atezolizumab and CDX-1127 (Varlilumab) With or Without the Addition of a Third Anti-cancer Drug, Cobimetinib, for Advanced-Stage Biliary Tract Cancer
A Phase 2 study of Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 and Recurrent Gallbladder Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
- 20
- Study locations
NCT04941287: Active Phase 2 study of Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 and Recurrent Gallbladder Carcinoma, sponsored by National Cancer Institute (NCI).
NCT04941287 is a Phase 2 study of Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 and Recurrent Gallbladder Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 57 participants, above the 33-participant average among 8 other Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 trials with a reported enrollment target (73% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04941287, a Phase 2 study of Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 and Recurrent Gallbladder Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Response is defined as a complete response (CR) (disappearance of all lesions) or partial response (PR) (\>= 30% decrease in the sum of target lesions) using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria after receiving at least one dose of the assigned study regimen.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- BIOLOGICAL Atezolizumab
- PROCEDURE Biopsy
- DRUG Cobimetinib
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Aventura - Aventura
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Kendall - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
California
- City of Hope Comprehensive Cancer Center - Duarte
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- University of California Davis Comprehensive Cancer Center - Sacramento
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
Colorado
- UCHealth University of Colorado Hospital - Aurora
Illinois
- Northwestern University - Chicago
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2021-12-15 |
| Est. Completion | 2026-04-29 |
| Phase | Phase 2 |
What the registry record for NCT04941287 still lists
NCT04941287 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, above the 33-participant average among 8 other Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 trials with a reported enrollment target (73% higher).
The record links to 10 conditions, with Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04941287 names 20 study sites across 9 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT04941287 about?
NCT04941287 is a clinical study titled "Testing A New Combination of Anti-cancer Immune Therapies, Atezolizumab and CDX-1127 (Varlilumab) With or Without the Addition of a Third Anti-cancer Drug, Cobimetinib, for Advanced-Stage Biliary Tract Cancer". 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 atezo...
What is the current status of trial NCT04941287?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2021-12-15. Estimated completion is 2026-04-29.
What conditions does trial NCT04941287 study?
This clinical trial studies the following conditions: Stage IV Intrahepatic Cholangiocarcinoma AJCC v8, Recurrent Gallbladder Carcinoma, Metastatic Intrahepatic Cholangiocarcinoma, Recurrent Intrahepatic Cholangiocarcinoma, Stage IV Distal Bile Duct Cancer AJCC v8.
What interventions are being tested in trial NCT04941287?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Atezolizumab (BIOLOGICAL), Biopsy (PROCEDURE), Cobimetinib (DRUG).
Who is sponsoring clinical trial NCT04941287?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04941287 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV Intrahepatic Cholangiocarcinoma AJCC v8
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 NCT04941287's enrollment target sits among peer trials
57 3rd of 8 higher than 6 of 8 other Stage IV Intrahepatic Cholangiocarcinoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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