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
Public ClinicalTrials.gov record NCT04941287. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04941287
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 57 participants
Conditions and interventions
Conditions
- Metastatic Distal Bile Duct Adenocarcinoma
- Metastatic Gallbladder Carcinoma
- Metastatic Intrahepatic Cholangiocarcinoma
- Recurrent Distal Bile Duct Adenocarcinoma
- Recurrent Gallbladder Carcinoma
- Recurrent Intrahepatic Cholangiocarcinoma
- Stage IV Distal Bile Duct Cancer AJCC v8
- Stage IV Gallbladder Cancer AJCC v8
- Stage IV Intrahepatic Cholangiocarcinoma AJCC v8
- Unresectable Liver Carcinoma
Interventions
- Atezolizumab Biological
- Biopsy Procedure
- Biospecimen Collection Procedure
- Cobimetinib Drug
- Computed Tomography Procedure
- Magnetic Resonance Imaging Procedure
- Varlilumab Drug
Biological · Procedure · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 15, 2021 (Actual)
- Primary completion
- Jan 2, 2024 (Actual)
- Completion
- Apr 29, 2026 (Estimated)
- Last update posted
- May 23, 2025
2021 – 2026
United States locations
- U.S. sites
- 29
- U.S. states
- 16
- U.S. cities
- 25
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Hospital in Arizona | Phoenix | Arizona | 85054 | — |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| Los Angeles General Medical Center | Los Angeles | California | 90033 | — |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| UCHealth University of Colorado Hospital | Aurora | Colorado | 80045 | — |
| UM Sylvester Comprehensive Cancer Center at Aventura | Aventura | Florida | 33180 | — |
| UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables | Florida | 33146 | — |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida | 33442 | — |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | — |
| UM Sylvester Comprehensive Cancer Center at Kendall | Miami | Florida | 33176 | — |
| UM Sylvester Comprehensive Cancer Center at Plantation | Plantation | Florida | 33324 | — |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | — |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | — |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| M D Anderson Cancer Center | Houston | Texas | 77030 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | — |
| University of Virginia Cancer Center | Charlottesville | Virginia | 22908 | — |
| University of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04941287, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 23, 2025 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04941287 live on ClinicalTrials.gov.