GEMINI-Hepatobiliary
Research type
Research Study
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)
IRAS ID
1007038
Contact name
Urvi Savani
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2022-502317-29
Research summary
This is a clinical study to learn more about the efficacy, safety, and how the body processes the medicine MEDI5752, given alone or in combination with bevacizumab or lenvatinib for people with hepatocellular carcinoma which cannot be treated with surgery (unresectable). The study will also help to better understand hepatocellular carcinoma and associated health problems. MEDI5752 is a new drug molecule that binds to two different proteins (called PD-1 and CTLA-4 ) at the same time, and is therefore called a “bispecific antibody”. It is a type of immunotherapy, meaning it works by boosting the ability of your immune system to detect and fight the cancer.
The study hopes to enrol 120 patients with unresectable hepatocellular carcinoma from around the world. First, patients will enter a screening period to check they are suitable for the study (approximately 70% of patients screened are expected to meet the requirements for entry). Then, each patient will be centrally allocated to one of three ‘arms’ (Arm 1: MEDI5752 alone, Arm 2: MEDI5752 + bevacizumab, or Arm 3: MEDI5752 + lenvatinib) and enter the treatment period. The length of time a patient will receive the treatment will depend on their individual response to it. After treatment is stopped, there will also be a follow-up period.
The study is funded and run by MedImmune Ltd, an AstraZeneca company.REC name
London - London Bridge Research Ethics Committee
REC reference
23/LO/0032
Date of REC Opinion
31 Aug 2023
REC opinion
Further Information Favourable Opinion