Full Title
A Phase II, Open-Label, Multi-Drug, Multi-Centre, Master Protocol to Evaluate the Efficacy and Safety of Novel Immunomodulators as Monotherapy and in Combination with Anticancer Agents in Participants with Advanced Hepatobiliary Cancer (GEMINI-Hepatobiliary)Purpose
Researchers are assessing MEDI5752 and AZD2936 with standard treatments in people with cancer. The people in this study have primary liver or biliary cancer, including biliary tract or gallbladder cancer, that spread or cannot be surgically removed (inoperable). In addition, they have not yet received treatment for the cancer.
MEDI5752 binds to two sites on immune cells. MEDI5752 is bispecific, meaning that it blocks both these signals using only one drug. This binding may boost the ability of the immune system to detect and fight cancer. MEDI5752 is given intravenously (by vein).
AZD2936 binds to one protein on the surface of cancer cells and to another on the surface of immune cells. AZD2936 may strengthen the immune system’s ability to fight cancer cells by activating your own cells to destroy your tumor. AZD2936 is given intravenously.
If you join this study and have primary liver cancer, you will be randomly assigned to get one of these treatments:
- MEDI5752 alone
- MEDI5752 with bevacizumab, which is given intravenously
- MEDI5752 with lenvatinib, which is taken orally (by mouth)
If you join this study and have biliary cancer, including biliary tract or gallbladder cancer, you will be randomly assigned to get one of these treatments:
- AZD2936 with gemcitabine and cisplatin, which are given intravenously
- MEDI5752 with gemcitabine and cisplatin
Who Can Join
To join this study, there are a few conditions. You must:
- Have hepatocellular carcinoma (primary liver cancer) or biliary cancer, including biliary tract cancer or gallbladder cancer, that has spread or is inoperable.
- Have not received prior treatment for this cancer.
- 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 and to see if you can join this study, please call Dr. Ghassan Abou-Alfa’s office at 646-888-4184.