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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
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502317-29-00
Acronym
D7987C00001
Enrollment
60
Registered
2023-05-30
Start date
2023-07-12
Completion date
Unknown
Last updated
2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Hepatobiliary Cancer

Brief summary

ORR for sub-study 1 and PFS for sub-study 2 determined by the Investigator at local site per RECIST 1.1., Incidence of AEs, AESIs, SAEs, and AEs leading to discontinuation of treatment

Detailed description

Duration Of Response (DOR) per RECIST 1.1 based on Investigator assessment, Disease Control Rate (DCR) at 12 and 24 weeks per RECIST 1.1 as assessed by the Investigator, Progression free survival (PFS) per RECIST 1.1 based on Investigator assessment, Overall Survival (OS), Serum concentrations of novel immunomodulators and derived PK parameters, Incidences of ADAs against novel immunomodulators in serum

Interventions

DRUGCisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung
DRUGGemcitabina Accord 100 mg/ml concentrato per soluzione per infusione.
DRUGAvastin 25 mg/ml concentrate for solution for infusion
DRUGCisplatino Accord Healthcare Italia 1 mg/ml concentrato per soluzione per infusione
DRUGGemsol 40 mg/ml concentrato per soluzione per infusione
DRUGRemsima 120 mg solution for injection in pre-filled pen
DRUGLENVIMA 4 mg hard capsules
DRUGCisplatino Sandoz 0
DRUG5 mg/ml – Concentrato per soluzione per infusione
DRUGRilvegostomig
DRUGMycophenolate Mofetil 500 mg film-coated tablets
DRUGvolrustomig
DRUGGemcitabin HEXAL® 40 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Sponsors

AstraZeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
ORR for sub-study 1 and PFS for sub-study 2 determined by the Investigator at local site per RECIST 1.1., Incidence of AEs, AESIs, SAEs, and AEs leading to discontinuation of treatment—

Secondary

MeasureTime frame
Duration Of Response (DOR) per RECIST 1.1 based on Investigator assessment, Disease Control Rate (DCR) at 12 and 24 weeks per RECIST 1.1 as assessed by the Investigator, Progression free survival (PFS) per RECIST 1.1 based on Investigator assessment, Overall Survival (OS), Serum concentrations of novel immunomodulators and derived PK parameters, Incidences of ADAs against novel immunomodulators in serum—

Countries

Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026