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)
1 other identifier
interventional
294
9 countries
60
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hepatocellular-carcinoma
Started Apr 2023
Longer than P75 for phase_2 hepatocellular-carcinoma
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2023
CompletedFirst Posted
Study publicly available on registry
March 20, 2023
CompletedStudy Start
First participant enrolled
April 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 28, 2027
April 17, 2026
April 1, 2026
3.5 years
March 2, 2023
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Objective response rate (ORR)
ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response), determined by the Investigator at local site per RECIST 1.1 (For HCC sub-study 1)
Through study completion, an average of 2 years
The number of participants with adverse events/serious adverse events
Number of participants with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline.
Through study completion, an average of 2 years
Progression free survival (PFS)
PFS is defined as the time from the start of studyintervention until progression per RECIST 1.1 as assessed by the Investigator at the local site or death due to any cause in the absence of progression, whichever occurs first. (For BTC sub-study 2)
Through study completion, an average of 2 years
Secondary Outcomes (9)
Duration Of Response (DOR)
Through study completion, an average of 2 years
Disease Control Rate (DCR)
At 12 and 24 weeks
Progression free survival (PFS)
Through study completion, an average of 2 years
Overall Survival (OS)
Through study completion, an average of 2 years
Anti Drug Antibody (ADA)
Through study completion, an average of 2 years
- +4 more secondary outcomes
Study Arms (7)
Cohort 1A
EXPERIMENTALVolrustomig monotherapy
Cohort 1B
EXPERIMENTALVolrustomig combination with bevacizumab
Cohort 1C
EXPERIMENTALVolrustomig combination with lenvatinib
Cohort 2A
EXPERIMENTALRilvegostomig combination with Gemcitabine and Cisplatin
Cohort 2B
EXPERIMENTALVolrustomig combination with Gemcitabine and Cisplatin
Cohort 1D
EXPERIMENTALVolrustomig combination with rilvegostomig and bevacizumab
Cohort 1E
EXPERIMENTALRilvegostomig combination with bevacizumab
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (60)
Research Site
Birmingham, Alabama, 35233, United States
Research Site
Costa Mesa, California, 92627, United States
Research Site
Los Angeles, California, 90089, United States
Research Site
Orange, California, 92868, United States
Research Site
Miami Beach, Florida, 33140, United States
Research Site
Dyer, Indiana, 46311, United States
Research Site
Kansas City, Kansas, 66103, United States
Research Site
New York, New York, 10065, United States
Research Site
Dallas, Texas, 75251, United States
Research Site
Fairfax, Virginia, 22031, United States
Research Site
Beijing, 100050, China
Research Site
Beijing, 100142, China
Research Site
Beijing, 101100, China
Research Site
Chengdu, 610000, China
Research Site
Chengdu, 610041, China
Research Site
Chongqing, 400030, China
Research Site
Fuzhou, 350007, China
Research Site
Guangzhou, 510060, China
Research Site
Guangzhou, 510515, China
Research Site
Harbin, 150081, China
Research Site
Hefei, 230001, China
Research Site
Hefei, 230022, China
Research Site
Hefei, 230601, China
Research Site
Nanchang, 330006, China
Research Site
Nanning, 530021, China
Research Site
Shandong, China
Research Site
Shanghai, 200032, China
Research Site
Xi'an, 710038, China
Research Site
Zhengzhou, 450008, China
Research Site
Hong Kong, 999077, Hong Kong
Research Site
Shatin, 00000, Hong Kong
Research Site
Florence, 50134, Italy
Research Site
Milan, 20132, Italy
Research Site
Naples, 80131, Italy
Research Site
Rozzano, 20089, Italy
Research Site
Chūōku, 104-0045, Japan
Research Site
Kashiwa, 277-8577, Japan
Research Site
Yokohama, 241-8515, Japan
Research Site
Seongnam-si, 463-712, South Korea
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 05505, South Korea
Research Site
Seoul, 06351, South Korea
Research Site
Barcelona, 08036, Spain
Research Site
Barcelona, 8035, Spain
Research Site
Madrid, 28007, Spain
Research Site
Madrid, 28040, Spain
Research Site
Pamplona, 31008, Spain
Research Site
Kaohsiung City, 80756, Taiwan
Research Site
Kaohsiung City, 833, Taiwan
Research Site
Liuying, 736, Taiwan
Research Site
Taichung, 40705, Taiwan
Research Site
Tainan, 70403, Taiwan
Research Site
Taipei, 10002, Taiwan
Research Site
Taipei, 11259, Taiwan
Research Site
Taoyuan District, 333, Taiwan
Research Site
Cambridge, CB2 0QQ, United Kingdom
Research Site
Edinburgh, EH4 2XU, United Kingdom
Research Site
London, NW3 2QG, United Kingdom
Research Site
Manchester, M20 4BX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2023
First Posted
March 20, 2023
Study Start
April 24, 2023
Primary Completion (Estimated)
October 27, 2026
Study Completion (Estimated)
October 28, 2027
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure