NCT05308901

Lenvatinib Plus Pembrolizumab In Patients With Immune Checkpoint Inhibitor Naïve Metastatic Uveal Melanoma

A Phase II Clinical Trial Evaluating The Combination Of Lenvatinib Plus Pembrolizumab In Patients With Treatment Naive Metastatic Uveal Melanoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Providence Health & Services · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of lenvatinib and pembrolizumab to treat metastatic uveal melanoma.

Detailed description

This is a phase II, single arm, single institution clinical trial. Adults (age≥18 years-old) with immune checkpoint inhibitor naïve metastatic uveal melanoma will be evaluated for eligibility. Eligible participants will be treated with the combination of Lenvatinib 20 mg daily + pembrolizumab 200 mg IV every 3 weeks for a maximum of 2 years.

Conditions

• Melanoma, Uveal

Interventions

Type	Name	Description
DRUG	Pembrolizumab	200 mg IV every 3 weeks for a maximum of 2 years.
DRUG	Lenvatinib	20 mg daily for a maximum of 2 years.

Timeline

• Start date: 2022-08-02
• Primary completion: 2024-12-03
• Completion: 2027-06-01
• First posted: 2022-04-04
• Last updated: 2025-07-25
• Results posted: 2025-07-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study