At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Volrustomig (drug), Bevacizumab (drug), Lenvatinib (drug), Rilvegostomig (drug)
- How long the study runs
- Study runs about 54 months (dates as stated)
- About the drug or intervention
- Volrustomig — drug: CTLA-4/Anti-PD-1 Bispecific Antibody · Bevacizumab — drug: 15 mg/kg, IV (in the vein) on day 1 of each 21 day cycle. · Lenvatinib — drug: Daily use per oral (8 mg capsules/day for participants \< 60 kg or 12 mg/day for participants ≥ 60 kg) of 21 day cycle. · Rilvegostomig — drug: anti- PD-1 and TIGIT bispecific antibody · Gemcitabine — drug: 1000 mg/m2, IV infusion · Cisplatin — drug: 25 mg/m2, IV infusion
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 294
- Started
- 2023-04-24
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for hepatocellular carcinoma
- • Phase2 - 294 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with hepatocellular carcinoma
Where?
- • Cambridge - Research Site
- • London - Research Site
- • Manchester - Research Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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 Volrustomig plus gemcitabine and cisplatin are investigated in approximately 90 evaluable participants with advanced BTC who have not received previous treatment for advanced/metastatic disease.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Age ≥18 years at the time of signing the ICF.
- ✓Provision of a signed and dated written ICF.
- ✓Confirmed that has grown locally or that has spread solid tumor specified in substudy based on histopathology.
- ✓Adequate organ and bone marrow function.
- ✓At least 1 measurable not previously irradiated lesion per (standard scan measurements)
Who cannot take part
- ✗History of allogeneic organ transplantation.
- ✗Active or prior documented autoimmune or inflammatory disorders.
- ✗Uncontrolled intercurrent illness.
- ✗History of another primary cancer, leptomeningeal carcinomatosis, and active primary immunodeficiency.
- ✗Active infection, brain metastases or spinal cord compression.
See the full criteria
Where Is This Study? (3 UK sites)
Research Site
Cambridge CB2 0QQ, United Kingdom
Research Site
London NW3 2QG, United Kingdom
Research Site
Manchester M20 4BX, United Kingdom