SOLARIS – A phase-II open-label study of pembrolizumab and lenvatinib in patients with advanced stage hepatocellular carcinoma who are refractory to atezolizumab and bevacizumab/ IO-based therapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515731-29-00

Acronym

SOLARIS

Enrollment

Registered

2024-10-25

Start date

2022-03-30

Completion date

2025-06-30

Last updated

2025-08-01

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

Conditions

advanced stage hepatocellular carcinoma

Brief summary

Objective response rate (ORR) – percentage of patients with complete response (CR) or partial response (PR) according to RECIST 1.1.

Detailed description

Progression free survival (PFS), Overall survival (OS), Safety and Toxcitiy

Interventions

DRUGLENVIMA 4 mg hard capsules

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR) – percentage of patients with complete response (CR) or partial response (PR) according to RECIST 1.1.	—

Secondary

Measure	Time frame
Progression free survival (PFS), Overall survival (OS), Safety and Toxcitiy	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026