Clinical trial · Interventional
A Study of Lenvatinib Plus Nivolumab in Participants With Hepatocellular Carcinoma
A Phase 1b Trial of Lenvatinib Plus Nivolumab in Subjects With Hepatocellular Carcinoma
NCT03418922CI-TRIAL-00078080completedPhase 1Results 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 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).
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1: Lenvatinib Plus Nivolumab
- description
- Participants will receive specified doses of lenvatinib (oral) and nivolumab (intravenous) on specified days.
- interventionNames
- Drug: Lenvatinib
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Part 2: Lenvatinib Plus Nivolumab
- description
- If tolerable in Part 1, participants will receive specified doses of lenvatinib and nivolumab on specified days until criteria for discontinuation are met.
- interventionNames
- Drug: Lenvatinib
- Drug: Nivolumab
Primary outcomes (8)
- measure
- Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.