Clinical trial · Interventional
A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors
A Phase 2, Randomized, Open-label Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Hepatocellular Carcinoma Who Are Naive to IO Therapy But Progressed on Tyrosine Kinase Inhibitors (RELATIVITY-073)
NCT04567615CI-TRIAL-00100417completedPhase 2Results postedClinicalTrials.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 effectiveness and safety of relatlimab in combination with nivolumab in participants with advanced liver cancer who have never been treated with immuno-oncology therapy, after prior treatment with tyrosine kinase inhibitor therapy.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatoma | Hepatocellular Carcinoma | ALIAS | 0.90 |
| Liver Cancer, Adult | Malignant Liver Neoplasm | CURATED_EXACT | 0.85 |
| Liver Cell Carcinoma | Hepatocellular Carcinoma | ALIAS | 0.90 |
| Liver Cell Carcinoma, Adult | Hepatocellular Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Biological | Nivolumab | ALIAS |
| Relatlimab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A : Nivolumab
- interventionNames
- Biological: Nivolumab
- type
- EXPERIMENTAL
- label
- Arm B : Nivolumab + Relatlimab Dose 1
- interventionNames
- Biological: Nivolumab
- Biological: Relatlimab
- type
- EXPERIMENTAL
- label
- Arm C : Nivolumab + Relatlimab Dose 2
- interventionNames
- Biological: Nivolumab
- Biological: Relatlimab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Must have a diagnosis of hepatocellular carcinoma (HCC) based on histological confirmation * Must have advanced/metastatic HCC * Have to be immunotherapy treatment-naive in the advanced/metastatic setting * Must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measurable untreated lesion * Child-Pugh score of 5 or 6 * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 for ECOG performance status scale Key Exclusion Criteria: * Known fibrolamellar HCC, sarcomatoid HCC, combined hepatocellular cholangiocarcinoma * Prior organ allograft or allogeneic bone marrow transplantation * No uncontrolled or significant cardiovascular disease * No active known autoimmune disease * Have received one or two lines of tyrosine kinase inhibitor therapies * Evidence of radiographic progression on or after the last line of tyrosine kinase inhibitor therapy Other protocol-defined inclusion/exclusion criteria apply
References
Publications (0)
Data not yet available
No reference posted for this study.