Phase 2
Completed N=266
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
Hepatocellular Carcinoma · Hepatoma · Liver Cancer
Source: ClinicalTrials.gov NCT04567615 ↗
Enrolled (actual)
266
Serious AEs
56.8%
Results posted
Oct 2024
Primary outcomePrimary: Objective Response Rate(ORR) Assessed by BICR — 13.3; 10.5; 12.5 Percentage
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate(ORR) Assessed by BICR |
13.3; 10.5; 12.5 | — |
| SECONDARY Disease Control Rate Assessed by BICR |
44.5; 44.7; 33.3 | — |
| SECONDARY Duration of Response Assessed by BICR |
5.82; NA; NA | — |
| SECONDARY Progression Free Survival(PFS) Assessed by BICR |
2.00; 2.00; 1.94 | — |
| SECONDARY Objective Response Rate Assessed by Investigator |
14.1; 13.2; 20.8 | — |
| SECONDARY Disease Control Rate Assessed by Investigator |
48.4; 50.9; 41.7 | — |
| SECONDARY Duration of Response Assessed by Investigator |
10.94; NA; 12.42 | — |
| SECONDARY Progression Free Survival(PFS) Assessed by Investigator |
3.32; 3.65; 1.94 | — |
| SECONDARY Overall Survival (OS) |
12.68; 12.19; 8.21 | — |
| SECONDARY Number of Participants With Adverse Events |
119; 108; 22 | — |
| SECONDARY Number of Participants With Serious Adverse Events |
43; 46; 14 | — |
| SECONDARY Number of Participants With Adverse Events Leading to Discontinuation |
13; 14; 5 | — |
| SECONDARY Death Summary |
67; 60; 18 | — |
| SECONDARY Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests |
25; 41; 6; 7; 16; 2 | — |
| SECONDARY Number of Participants With Clinical Laboratory Abnormalities in Thyroid Tests |
38; 42; 2; 14; 18; 1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04567615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.