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ACTIVE NOT RECRUITING 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

NCT04941287 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 57 participants
Start Date 2021-12-15
Est. Completion 2026-04-29
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04941287

The ClinicalTrials.gov registry entry for NCT04941287 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04941287 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04941287?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial