Lenvatinib + Pembrolizumab for Uveal Melanoma

Recruiting in Palo Alto (17 mi)

Overseen ByMatthew Taylor, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Providence Health & Services

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a combination of two drugs, lenvatinib and pembrolizumab, to treat adults with metastatic uveal melanoma. Lenvatinib is taken as a daily pill, and pembrolizumab is given through an IV periodically. The goal is to see if these drugs can stop cancer growth and help the immune system fight the cancer. Pembrolizumab is an immune checkpoint inhibitor that has shown promise in treating various cancers, including melanoma, by enhancing the immune system's ability to fight cancer.

Eligibility Criteria

This trial is for adults with a confirmed diagnosis of metastatic uveal melanoma who haven't been treated with certain immune therapies before. Participants must have measurable disease, provide tissue samples, and have good organ function and performance status. They should agree to use contraception and not be pregnant or breastfeeding.

Inclusion Criteria

The participant (or legally acceptable representative if applicable) provides written informed consent for the trial

I have provided a sample of my tumor that has not been treated with radiation.

I am fully active or can carry out light work.

+7 more

Exclusion Criteria

You have uncorrected problems with the minerals in your body.

I have no health issues that could affect the study's results.

You have high levels of protein in your urine.

+21 more

Participant Groups

The study tests the effectiveness of combining lenvatinib with pembrolizumab in treating metastatic uveal melanoma. It aims to see how well these drugs work together for patients who haven't received similar treatments previously.

1Treatment groups

Experimental Treatment

Group I: Pembrolizumab + LenvatinibExperimental Treatment2 Interventions

Lenvatinib 20 mg daily plus pembrolizumab 200 mg IV every 3 weeks.

Lenvatinib is already approved in United States, European Union, European Union for the following indications:

🇺🇸 Approved in United States as Lenvima for: