Lenvatinib + Pembrolizumab for Uveal Melanoma

Overseen by Matthew 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.

Research Team

Matthew Taylor, MD

Principal Investigator

Providence Health & Services

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.

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.

Treatment Details

Interventions

• Lenvatinib (Tyrosine Kinase Inhibitor)
• Pembrolizumab (Checkpoint Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Pembrolizumab + Lenvatinib Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Providence Health & Services

Lead Sponsor

Trials

131

Recruited

827,000+

Dr. Laurel Soot

Providence Health & Services

Chief Medical Officer since 2024

MD, FACS

Erik Wexler

Providence Health & Services

Chief Executive Officer

Bachelor's degree in Business Administration from the University of Massachusetts Amherst

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Eisai Inc.

Industry Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University