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)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic Hospital in Arizona โ Phoenix, Arizona
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (29 Sites)
Showing the first 25 of 29 sites.
- Mayo Clinic Hospital in Arizona โ Phoenix, Arizona
- City of Hope Comprehensive Cancer Center โ Duarte, California
- Los Angeles General Medical Center โ Los Angeles, California
- USC / Norris Comprehensive Cancer Center โ Los Angeles, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center โ Orange, California
- University of California Davis Comprehensive Cancer Center โ Sacramento, California
- UCHealth University of Colorado Hospital โ Aurora, Colorado
- UM Sylvester Comprehensive Cancer Center at Aventura โ Aventura, Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables โ Coral Gables, Florida
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach โ Deerfield Beach, Florida
- University of Miami Miller School of Medicine-Sylvester Cancer Center โ Miami, Florida
- UM Sylvester Comprehensive Cancer Center at Kendall โ Miami, Florida
- UM Sylvester Comprehensive Cancer Center at Plantation โ Plantation, Florida
- Emory University Hospital Midtown โ Atlanta, Georgia
- Emory University Hospital/Winship Cancer Institute โ Atlanta, Georgia
- Emory Saint Joseph's Hospital โ Atlanta, Georgia
- Northwestern University โ Chicago, Illinois
- Johns Hopkins University/Sidney Kimmel Cancer Center โ Baltimore, Maryland
- Mayo Clinic in Rochester โ Rochester, Minnesota
- Roswell Park Cancer Institute โ Buffalo, New York
- Laura and Isaac Perlmutter Cancer Center at NYU Langone โ New York, New York
- Wake Forest University Health Sciences โ Winston-Salem, North Carolina
- Ohio State University Comprehensive Cancer Center โ Columbus, Ohio
- Vanderbilt University/Ingram Cancer Center โ Nashville, Tennessee
- M D Anderson Cancer Center โ Houston, Texas
๐ Contact the Study Coordinator
Phone: (800) 664-4580
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.