An official website of the United States government
Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
Trial Status: active
GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel
immunomodulators alone and in combination with other anticancer drugs in participants
with specified advanced solid tumors.
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.
Additional locations may be listed on ClinicalTrials.gov for NCT05775159.
