Clinical trial · Interventional
A Study of Nivolumab and Relatlimab in Combination With Bevacizumab in Advanced Liver Cancer
A Phase 1/2, Safety Confirmation, Placebo-controlled, Randomized Study of Nivolumab in Combination With Relatlimab and Bevacizumab in Treatment-naive Advanced/Metastatic Hepatocellular Carcinoma
NCT05337137CI-TRIAL-00100656RELATIVITY-106completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the safety and effectiveness of triplet therapy of nivolumab, relatlimab and bevacizumab versus nivolumab and bevacizumab in participants with untreated advanced/metastatic hepatocellular carcinoma (HCC).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Placebo | Other | — | UNRESOLVED |
| Relatlimab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: Relatlimab + Nivolumab + Bevacizumab
- interventionNames
- Drug: Relatlimab
- Drug: Nivolumab
- Drug: Bevacizumab
- type
- EXPERIMENTAL
- label
- Arm B: Placebo + Nivolumab + Bevacizumab
- interventionNames
- Drug: Nivolumab
- Drug: Bevacizumab
- Other: Placebo
Primary outcomes (2)
- measure
- Incidence of dose-limiting toxicities (DLTs)
- timeFrame
- Up to 6 weeks
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed advanced/metastatic hepatocellular carcinoma (HCC) * Naïve to systemic therapy for advanced/metastatic HCC (prior neo-adjuvant or adjuvant immunotherapy is permitted if recurrence occurs ≥ 6 months after treatment completion and the case is discussed with BMS medical team) * Child-Pugh score of 5 or 6 (ie, Child-Pugh A) * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Exclusion Criteria: * Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC * Prior allogenic stem cell or solid organ transplantation * Untreated symptomatic central nervous system (CNS) metastases * Clinically significant ascites as defined by: i) Prior ascites that required treatment and requires on-going prophylaxis, or ii) Current ascites requiring treatment Other protocol-defined inclusion/exclusion criteria apply
References
Publications (0)
Data not yet available
No reference posted for this study.