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)
Sponsor: AstraZeneca
This observational or N/A phase trial investigates Biliary Tract Cancer and Hepatocellular Carcinoma and is currently actively recruiting participants. AstraZeneca leads this study, which shows 22 recorded versions since 2023 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)This Phase II, open-label, uncontrolled, multicentre study evaluating the preliminary efficacy and safety of Volrustomig or Rilvegostomig as monotherapy (MONO) and/or in combination with anticancer agents (COMBO) in participants with advanced hepatobiliary cancer (e.g., HCC, BTC, etc.).
This study has a modular design with independent substudies. In Substudy 1, Volrustomig and Rilvegostomig will be evaluated as monotherapy and/or in combination with other anticancer drugs in approximately 200 evaluable participants with advanced HCC.
In Substudy 2, the efficacy and safety of Rilvegostomig or Volrustomig plus gemcitabine and cisplatin are investigated in approximately 90 evaluable participants with advanced BTC who have not received previous treatment for advanced/metastatic disease.
This Phase II, open-label, uncontrolled, multicentre study evaluating the preliminary efficacy and safety of Volrustomig or Rilvegostomig as monotherapy (MONO) and/or in combination with anticancer agents (COMBO) in participants with advanced hepatobiliary cancer (e.g., HCC, BTC, etc.).
This study has a modular design with independent substudies. In Substudy 1, Volrustomig and Rilvegostomig will be evaluated as monotherapy and/or in combination with other anticancer drugs in approximately 200 evaluable participants with advanced HCC.
In Substudy 2, the efficacy and safety of Rilvegostomig or Volrustomig plus gemcitabine and cisplatin are investigated in approximately 90 evaluable participants with advanced BTC who have not received previous treatment for advanced/metastatic disease.
Status Flow
Change History
22 versions recorded-
Apr 18, 2026 — Present [daily]
Recruiting
Phase: PHASE2 → None
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Feb 2026 — Apr 2026 [monthly]
Recruiting PHASE2
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Dec 2025 — Feb 2026 [monthly]
Recruiting PHASE2
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Sep 2025 — Dec 2025 [monthly]
Recruiting PHASE2
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Aug 2025 — Sep 2025 [monthly]
Recruiting PHASE2
▶ Show 17 earlier versions
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Jun 2025 — Aug 2025 [monthly]
Recruiting PHASE2
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May 2025 — Jun 2025 [monthly]
Recruiting PHASE2
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Apr 2025 — May 2025 [monthly]
Recruiting PHASE2
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Mar 2025 — Apr 2025 [monthly]
Recruiting PHASE2
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Dec 2024 — Mar 2025 [monthly]
Recruiting PHASE2
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Oct 2024 — Dec 2024 [monthly]
Recruiting PHASE2
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Sep 2024 — Oct 2024 [monthly]
Recruiting PHASE2
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Aug 2024 — Sep 2024 [monthly]
Recruiting PHASE2
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Jul 2024 — Aug 2024 [monthly]
Recruiting PHASE2
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May 2024 — Jul 2024 [monthly]
Recruiting PHASE2
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Apr 2024 — May 2024 [monthly]
Recruiting PHASE2
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Mar 2024 — Apr 2024 [monthly]
Recruiting PHASE2
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Nov 2023 — Mar 2024 [monthly]
Recruiting PHASE2
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Oct 2023 — Nov 2023 [monthly]
Recruiting PHASE2
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Aug 2023 — Oct 2023 [monthly]
Recruiting PHASE2
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Jun 2023 — Aug 2023 [monthly]
Recruiting PHASE2
Status: Not Yet Recruiting → Recruiting
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Apr 2023 — Jun 2023 [monthly]
Not Yet Recruiting PHASE2
First recorded
Eligibility Summary
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.
Contact Information
- AstraZeneca
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Barcelona, Spain , Barcelona, Spain , Beijing, China , Beijing, China , Beijing, China , Birmingham, United States , Cambridge, United Kingdom , Chengdu, China , Chengdu, China , Chongqing, China and 50 more locations