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 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria