Clinical trial · Interventional
Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| Rilvegostomig | Drug | — | UNRESOLVED |
| Volrustomig | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Cohort 1A
- description
- Volrustomig monotherapy
- interventionNames
- Drug: Volrustomig
- type
- EXPERIMENTAL
- label
- Cohort 1B
- description
- Volrustomig combination with bevacizumab
- interventionNames
- Drug: Volrustomig
- Drug: Bevacizumab
- type
- EXPERIMENTAL
- label
- Cohort 1C
- description
- Volrustomig combination with lenvatinib
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. * Uncontrolled intercurrent illness. * History of another primary malignancy, leptomeningeal carcinomatosis, and active primary immunodeficiency. * Active infection, brain metastases or spinal cord compression. * Participants co-infected with HBV and hepatitis D virus (HDV). * Previous treatment in the present study. * For substudy 1, history of hepatic encephalopathy within 12 months prior to treatment allocation.
References
Publications (0)
Data not yet available