Study of novel immunomodulators as monotherapy and in combination with anticancer agents in participants with advanced Hepatobiliary Cancer
Study identifier:D7987C00001
ClinicalTrials.gov identifier:NCT05775159
EudraCT identifier:N/A
CTIS identifier:2022-502317-29-00
Recruiting
Official Title
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)
Medical condition
Hepatocellular Carcinoma
Phase
Phase 2
Healthy volunteers
No
Study drug
Volrustomig, Bevacizumab, Lenvatinib, Rilvegostomig, Gemcitabine, Cisplatin
Sex
All
Estimated Enrollment
260
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 24 Apr 2023
Estimated Primary Completion Date: 26 Nov 2025
Estimated Study Completion Date: 25 Nov 2026
Study design
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Cohort 1A Volrustomig monotherapy | Drug: Volrustomig CTLA-4/Anti-PD-1 Bispecific Antibody |
| Experimental: Cohort 1B Volrustomig combination with bevacizumab | 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. |
| Experimental: Cohort 1C Volrustomig combination with lenvatinib | Drug: Volrustomig CTLA-4/Anti-PD-1 Bispecific Antibody 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. |
| Experimental: Cohort 2A Rilvegostomig combination with Gemcitabine and Cisplatin | Drug: Rilvegostomig anti- PD-1 and TIGIT bispecific antibody Drug: Gemcitabine 1000 mg/m2, IV infusion Drug: Cisplatin 25 mg/m2, IV infusion |
| Experimental: Cohort 2B Volrustomig combination with Gemcitabine and Cisplatin | Drug: Volrustomig CTLA-4/Anti-PD-1 Bispecific Antibody Drug: Gemcitabine 1000 mg/m2, IV infusion Drug: Cisplatin 25 mg/m2, IV infusion |
| Experimental: Cohort 1D Volrustomig combination with rilvegostomig and bevacizumab | 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: Rilvegostomig anti- PD-1 and TIGIT bispecific antibody |
| Experimental: Cohort 1E Rilvegostomig combination with bevacizumab | 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: Rilvegostomig anti- PD-1 and TIGIT bispecific antibody |
