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)
AstraZeneca
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.
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * History of allogeneic organ transplantation. * Active or prior documented autoimmune or inflammatory disorders. * Uncontro…
Interventions
- DrugVolrustomig
CTLA-4/Anti-PD-1 Bispecific Antibody
- DrugBevacizumab
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.
- DrugLenvatinib
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.
- DrugRilvegostomig
anti- PD-1 and TIGIT bispecific antibody
- DrugGemcitabine
1000 mg/m2, IV infusion
- DrugCisplatin
25 mg/m2, IV infusion
Locations (60)
- Research SiteBirmingham, Alabama
- Research SiteCosta Mesa, California
- Research SiteLos Angeles, California
- Research SiteOrange, California
- Research SiteMiami Beach, Florida
- Research SiteDyer, Indiana