Full Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Global Study of Rilvegostomig in Combination with Chemotherapy as Adjuvant Treatment After Resection of Biliary Tract Cancer with Curative Intent (ARTEMIDE-Biliary01) (WCG IRB)Purpose
Researchers want to see if adding rilvegostomig to chemotherapy is better than chemotherapy alone for biliary tract cancer. The people in this study will be getting one of these treatments after surgery to remove their biliary tract cancer. It is hoped that the treatment will reduce the chance of the cancer coming back.
Rilvegostomig may help your immune system fight your cancer. It sticks to and blocks signaling from two molecules called PD-1 and TIGIT on immune cells. Cancer cells use PD-1 and TIGIT to avoid being attacked by the immune system so they can grow and survive. By stopping cancer cells from using these molecules, rilvegostomig may help your immune system find and attack cancer cells.
If you join this study, you will be randomly assigned to get one of these treatments:
- Rilvegostomig and chemotherapy (capecitabine or gemcitabine/cisplatin)
- Chemotherapy plus a placebo (inactive drug)
Rilvegostomig, gemcitabine, and cisplatin are given intravenously (by vein) and capecitabine is taken orally (by mouth).
Who Can Join
To join this study, there are a few conditions. You must:
- Have intrahepatic or extrahepatic cholangiocarcinoma or gallbladder cancer that has been taken out with surgery.
- Have had biliary tract cancer surgery no more than 3 months 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.