A Phase 3 Study of Standard Treatment With and Without Zanidatamab for People With Biliary Tract Cancer

Full Title

An Open-label Randomized Trial of the Efficacy and Safety of Zanidatamab with Standard-of-care Therapy Against Standard-of-care Therapy Alone for Advanced HER2-positive Biliary Tract Cancer

Purpose

Researchers want to see if adding zanidatamab to standard treatment works well against biliary tract cancer. The people in this study have biliary tract cancer that has spread or cannot be removed with surgery. In addition, their cancers make a protein called HER2.

Cancer cells that make too much HER2 can grow and divide uncontrollably. Zanidatamab works by blocking HER2.

If you join this study, you will be randomly assigned to get one of these treatments:

• Zanidatamab plus standard treatment (cisplatin and gemcitabine plus immunotherapy)
• Standard treatment with cisplatin and gemcitabine plus immunotherapy (durvalumab or pembrolizumab) 

 All of these medications are given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

• Have biliary tract cancer that has spread or cannot be taken out with surgery and makes high levels of HER2. Examples of biliary tract cancer include gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma.
• Have recovered from the serious side effects of prior anti-cancer treatments before getting the study therapy.
• Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
• Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. James Harding’s office at 646-888-4314.