Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer

Launched by ASTRAZENECA · Mar 17, 2023

Keywords

ClinConnect Summary

The GEMINI-Hepatobiliary study is a clinical trial that is testing new treatments called immunomodulators, both on their own and alongside other cancer medications, for people with advanced liver and bile duct cancers. The goal is to see how well these treatments work, how safe they are, and how well patients can tolerate them. This study is currently looking for participants aged 18 and older who have been diagnosed with specific types of advanced solid tumors and can provide a tumor sample for testing.

To join the study, participants must have a measurable cancer lesion that hasn't been treated with radiation before, and they should expect to live for at least 12 more weeks. It's important that participants have good organ and bone marrow function. However, people with certain conditions, like recent organ transplants or severe infections, may not be eligible. Those who join the trial will be monitored closely, and they can expect to receive either the new treatment or a combination of treatments while contributing to important research aimed at improving cancer care.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Age ≥18 years at the time of signing the ICF.
• • Provision of a signed and dated written ICF.
• • Confirmed locally advanced or metastatic solid tumor specified in substudy based on histopathology.
• • Adequate organ and bone marrow function.
• • At least 1 measurable not previously irradiated lesion per RECIST 1.1
• • Life expectancy of at least 12 weeks at the time of screening.
• • Willing and able to provide an adequate tumor sample.
• Exclusion Criteria:
• • History of allogeneic organ transplantation.
• • Active or prior documented autoimmune or inflammatory disorders.
• • Uncontrolled intercurrent illness.
• • History of another primary malignancy, leptomeningeal carcinomatosis, and active primary immunodeficiency.
• • Active infection, brain metastases or spinal cord compression.
• • Participants co-infected with HBV and hepatitis D virus (HDV).
• • Previous treatment in the present study.
• • For substudy 1, history of hepatic encephalopathy within 12 months prior to treatment allocation.