NCT05775159

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 294 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hepatocellular Carcinoma
• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	Volrustomig	CTLA-4/Anti-PD-1 Bispecific Antibody
DRUG	Bevacizumab	15 mg/kg, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.
DRUG	Lenvatinib	Daily use per oral (8 mg capsules/day for participants \< 60 kg or 12 mg/day for participants ≥ 60 kg) of 21 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.
DRUG	Rilvegostomig	anti- PD-1 and TIGIT bispecific antibody
DRUG	Gemcitabine	1000 mg/m2, IV infusion
DRUG	Cisplatin	25 mg/m2, IV infusion

Timeline

• Start date: 2023-04-24
• Primary completion: 2026-10-27
• Completion: 2027-10-28
• First posted: 2023-03-20
• Last updated: 2026-04-17

Locations

60 sites across 9 countries: United States, China, Hong Kong, Italy, Japan, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study