Phase 1
Completed N=30
A Study of Lenvatinib Plus Nivolumab in Participants With Hepatocellular Carcinoma
Carcinoma, Hepatocellular
Source: ClinicalTrials.gov NCT03418922 ↗
Enrolled (actual)
30
Serious AEs
50.0%
Results posted
Jun 2024
Primary outcomePrimary: Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs) — 0 Participants
Summary
The primary objective of this study is to evaluate the tolerability and safety of a combination of lenvatinib plus nivolumab in participants with hepatocellular carcinoma (HCC).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs) |
— | — |
| PRIMARY Part 1 and Part 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
6; 24; 3; 12 | — |
| PRIMARY Mean Change From Baseline in Vital Sign: Weight |
2.82; -3.10 | — |
| PRIMARY Mean Change From Baseline in Vital Sign: Body Mass Index |
1.10; -1.12 | — |
| PRIMARY Mean Change From Baseline in Vital Sign: SpO2 (Oxygen Saturation) |
0.2; -0.6 | — |
| PRIMARY Number of Participants With Treatment-Emergent Markedly Abnormal Laboratory Values (TEMAVs) |
0; 2; 0; 0; 2; 1 | — |
| PRIMARY Number of Participants With Highest Post-Baseline Values for Eastern Cooperative Oncology Group Performance Status (ECOG-PS) Scale |
0; 15; 5; 6; 0; 1 | — |
| PRIMARY Change From Baseline in Left Ventricular Ejection Fraction (LVEF) |
0.0; 0.4 | — |
| SECONDARY Part 1 and Part 2: Objective Response Rate (ORR) Based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Assessed by Investigator Review |
66.7; 79.2 | — |
| SECONDARY Part 1, Cmax: Maximum Observed Plasma Concentration for Lenvatinib |
93.3; 122 | — |
| SECONDARY Part 1, Tmax: Time to Reach the Cmax for Lenvatinib |
1.45; 3.97 | — |
| SECONDARY Part 1, AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero Time to the Last Measurable Point for Lenvatinib |
882; 1380; 1410; 1920 | — |
| SECONDARY Part 1, AUC(0-Inf): Area Under the Plasma Concentration-time Curve From Zero to Infinity for Lenvatinib |
987; 1630 | — |
| SECONDARY Part 1, t1/2: Terminal Elimination Phase Half-Life for Lenvatinib |
6.77; 8.95 | — |
| SECONDARY Part 1, CL/F: Apparent Total Clearance for Lenvatinib |
8.09; 7.37 | — |
| SECONDARY Part 1, Vz/F: Apparent Terminal Volume of Distribution for Lenvatinib |
79.0; 95.1 | — |
| SECONDARY Part 1, Css,Max: Maximum Observed Plasma Concentration at Steady State for Lenvatinib |
139; 164 | — |
| SECONDARY Part 1, Css,Min: Minimum Observed Plasma Concentration at Steady State for Lenvatinib |
13.5; 28.2 | — |
| SECONDARY Part 1, Tss,Max: Time to Maximum Observed Concentration at Steady State For Lenvatinib |
3.94; 3.93 | — |
| SECONDARY Part 1, Rac (Cmax): Accumulation Ratio of Cmax for Lenvatinib |
1.48; 1.28 | — |
| SECONDARY Part 1, Rac (AUC0-t): Accumulation Ratio of AUC(0-t) for Lenvatinib |
1.59; 1.38 | — |
| SECONDARY Part 1, MRT: Mean Residence Time for Lenvatinib |
10.9; 13.7 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must have confirmed diagnosis of hepatocellular carcinoma (HCC) with any of the following criteria:
- Histologically or cytologically confirmed diagnosis of HCC, excluding fibrolamellar, sarcomatoid or mixed cholangio-HCC tumors
- Clinically confirmed diagnosis of HCC according to American Association for the Study of Liver Diseases criteria, including cirrhosis of any etiology and/or chronic hepatitis B or C infection
- Part 1: HCC for which no other appropriate therapy is available; Part 2: No prior systemic therapy for advanced/unresectable HCC
- Participants categorized to stage B (not applicable for transarterial chemoembolization), or stage C based on Barcelona Clinic Liver Cancer staging system
- Child-Pugh score A
- Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 to 1
- Age greater than or equal to (>=) 20 years at the time of informed consent
Exclusion Criteria
- Active co-infection with hepatitis B and hepatitis C
- Participants with any active, known, or suspected autoimmune disease
- Participants being treated with drugs that strongly inhibit or induce CYP3A4 and that may be possibly used during this study
- Females who are breastfeeding or pregnant
Data sourced from ClinicalTrials.gov (NCT03418922). 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.