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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2025-05-23

Study results available
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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.

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

BIOLOGICAL

Atezolizumab

Given IV

PROCEDURE

Biopsy

Undergo tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

DRUG

Cobimetinib

Given PO

PROCEDURE

Computed Tomography

Undergo a CT scan

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Varlilumab

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Nilofer S Azad · JHU Sidney Kimmel Comprehensive Cancer Center LAO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-15
Primary Completion
2024-01-02
Completion
2026-04-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04941287 on ClinicalTrials.gov