Home › Trials › NCT05775159

Testing new immunomodulators for advanced liver and bile duct cancers

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)

PHASE2 · AstraZeneca · NCT05775159

This study is testing new immune-boosting treatments for people with advanced liver and bile duct cancers to see if they are safe and effective.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment294 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca (industry)
Locations60 sites (Birmingham, Alabama and 59 other locations)
Trial IDNCT05775159 on ClinicalTrials.gov

What this trial studies

This Phase II, open-label, multicenter study evaluates the efficacy and safety of novel immunomodulators, Volrustomig and Rilvegostomig, both as standalone treatments and in combination with other anticancer agents for patients with advanced hepatobiliary cancers. The study includes two substudies: one focusing on hepatocellular carcinoma (HCC) and the other on biliary tract cancer (BTC), with a total of approximately 260 participants. Participants will receive treatment based on their specific cancer type and prior treatment history, and the study aims to assess both the safety and preliminary effectiveness of these new therapies.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed advanced hepatobiliary cancers who have not received prior treatment for metastatic disease.

Not a fit: Patients with active autoimmune disorders, uncontrolled illnesses, or those who have received previous treatments in this study may not benefit.

Why it matters

Potential benefit: If successful, this study could provide new treatment options for patients with advanced hepatobiliary cancers, potentially improving outcomes and survival rates.

How similar studies have performed: Other studies have shown promise with immunomodulators in cancer treatment, but this specific combination approach is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 59 other locations

+10 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Hepatocellular Carcinoma, Biliary Tract Cancer, Hepatobiliary cancer, Hepatocellular carcinoma, Biliary tract cancer, GEMINI-Hepatobiliary, MEDI5752, AZD2936

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.