An Open-Label Phase 1b Trial of Lenvatinib Plus Pembrolizumab in Subjects With Hepatocellular Carcinoma

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223439

Enrollment

104

Registered

2017-01-19

Start date

2017-02-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Interventions

investigational material(s) Generic name etc : E7080 INN of investigational material : lenvatinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational m

participants weighing less than 60 kg will receive 8 mg QD. Generic name etc : MK-3475 INN of investigational material : Pembrolizumab Therapeutic category code : 429 Other antitumor agents Dosage and

participants weighing less than 60 kg will receive 8 mg QD. control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Inv

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Confirmed diagnosis of hepatocellular carcinoma (HCC) (2)HCC for which no other appropriate therapy is available. Note: Expansion Part: No prior systemic therapy for advanced/unresectable HCC (3)Stage B (not applicable for transarterial chemoembolization [TACE]), or stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system (4)At least 1 measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) (5)Child-Pugh score A (6)Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1 (7)Adequately controlled blood pressure (8)Adequate renal function (9)Adequate bone marrow function (10)Adequate blood coagulation function (11)Adequate liver function (12)Males or females age >= 18 years at the time of informed consent (13)Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol

Exclusion criteria

Exclusion criteria: (1)Prior treatment with lenvatinib or any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent (2)Any current brain or subdural metastases (3)Active malignancy (except for HCC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 36 months (4)Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial

Design outcomes

Primary

Measure	Time frame
safety efficacy Dose-limiting toxicity (DLT) of lenvatinib and pembrolizumab during Cycle 1	—

Secondary

Measure	Time frame
efficacy pharmacokinetics pharmacogenomics other -	—

Countries

Europe, Japan, North America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026