NCT07365839

Cemiplimab +/- Fianlimab Post Y90 Radioembolization in Patients With Hepatocellular Carcinoma

CLeAR: Pilot Study to Evaluate the Efficacy of Cemiplimab (PD-1 Inhibition) With or Without Fianlimab (LAG-3 Inhibition) After Y90 Radioembolization in Patients With Hepatocellular Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized, 2-arm, non-comparative, pilot study assessing the efficacy of cemiplimab with or without fianlimab after treatment with yttrium-90 (Y90).

Detailed description

At 2-8 weeks after yttrium-90 (Y90) radioembolization, patients will be randomized to receive treatment with cemiplimab or with a fixed-dose combination of cemiplimab and fianlimab. If Y90 is administered in 2 treatments, the first dose of the study treatment must be given no more than 12 weeks after first Y90 treatment and at least 2 weeks after the second treatment. Patients will receive the assigned study treatment once per 3-week cycle and will continue treatment for up to 17 cycles (approximately 1 year) or until disease progression or intolerance.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Arm 1 cemiplimab	Cemiplimab 350mg IV every 3 weeks up to 1 year.
DRUG	Arm 2 cemiplimab and fianlimab	Cemiplimab 350mg IV and fianlimab 1600mg every 3 weeks up to 1 year

Timeline

• Start date: 2026-07-01
• Primary completion: 2035-02-28
• Completion: 2035-02-28
• First posted: 2026-01-26
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study