Atezolizumab With or Without Cobimetinib in Treating Patients With Metastatic Bile Duct Cancer That Cannot Be Removed by Surgery or Gallbladder Cancer
Part of paid clinical trials in Duarte, California.
- Sponsor
- National Cancer Institute (NCI)
- Study ID
- NCT03201458
- Phase
- PHASE2
- Status
- Completed
Conditions
- Gallbladder Carcinoma
- Metastatic Cholangiocarcinoma
- Stage III Intrahepatic Cholangiocarcinoma AJCC v8
- Stage IV Intrahepatic Cholangiocarcinoma AJCC v8
- Unresectable Cholangiocarcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Atezolizumab — DRUGGiven IV
- Biopsy — PROCEDUREUndergo tumor biopsy
- Biospecimen Collection — PROCEDUREUndergo collection of blood samples
- Cobimetinib — DRUGGiven PO
- Computed Tomography — PROCEDUREUndergo CT
- Magnetic Resonance Imaging — PROCEDUREUndergo MRI
Study Details
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.
Key Dates
- Start date
- Feb 8, 2018
- Status verified
- Feb 2024
- Primary completion
- Aug 7, 2020
- Completion
- Feb 19, 2024
Study Design
- Enrollment
- 86 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A (atezolizumab)Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and collection of blood samples throughout the trial and undergo tumor biopsy on study.
- Experimental: Arm B (atezolizumab, cobimetinib)Patients receive atezolizumab IV over 30-60 minutes on days 1 and 15 and cobimetinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI and collection of blood samples throughout the trial and undergo tumor biopsy on study.
Primary Outcome Measure
Progression Free Survival (PFS) [ Time Frame: From date of randomization to time of progression or death, assessed up to 1 year ]
Locations (41)
Find similar trials in Duarte, CA
Related Studies
- Radioembolization With Tremelimumab and Durvalumab for Locally Advanced Unresectable or Oligo-Metastatic Intrahepatic CholangiocarcinomaPHASE1 · Recruiting · Mayo Clinic · Jacksonville, Florida
- Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene AlterationsPHASE1 · Recruiting · Tyra Biosciences, Inc · San Francisco, California
- Trifluridine/Tipiracil + Oxaliplatin in Participants With Advanced or Metastatic Biliary Tract CancerPHASE2 · Recruiting · Case Comprehensive Cancer Center · Cleveland, Ohio
- AB801 in Combination With Chemotherapy and Immunotherapy for the Treatment of Patients With Borderline Resectable, Locally Advanced or Metastatic Cholangiocarcinoma or Pancreatic CancerPHASE1 · Not Yet Recruiting · Jonsson Comprehensive Cancer Center · Los Angeles, California