NCT05775159Active, not recruitingPhase 2
Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
A Phase II, Open-Label, Multi-Drug, Multi-Center, 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)
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 294 (estimated)
- First submitted
- 2 Mar 2023
- Start date
- 24 Apr 2023
- Primary completion date
- 27 Oct 2026
- Lead sponsor
- AstraZeneca
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05775159
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 294
- From 24 Apr 2023 to the primary completion date, 27 Oct 2026
- 35 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active or prior documented autoimmune or inflammatory disorders.
- Previous treatment in the present study.
- For substudy 1, history of hepatic encephalopathy within 12 months prior to treatment allocation.
Other illness
- History of allogeneic organ transplantation.
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (35)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.