Leap 7902-004

For patients with Advanced Melanoma Previously Exposed to an Anti-PD-1/L1 Agent

Efficacy and Safety of Lenvatinib Plus Pembrolizumab for Advanced Melanoma in Anti-Programmed Death-1/Programmed Death-Ligand 1 -Exposed Participants

This study will evaluate the safety and efficacy of combination therapy of lenvatinib (E7080/MK-7902) and pembrolizumab following approximately 2 years of pembrolizumab therapy and approximately 2 years or more lenvatinib therapy in adult participants with unresectable or advanced melanoma who have been exposed to anti-PD-1/L1 agents approved for unresectable or metastatic melanoma. No statistical hypothesis will be tested in this study.

Status:

Recruiting

Phase 2 Icon

Trial Phase

The investigational drug is being studied in a group of patients to see if it is safe and effective.

Eligibility

About the Trial

All of the participants who enroll in the trial will receive medication. All of the participants will receive pembrolizumab and lenvatinib.

  • You will be receiving lenvatinib 20 mg daily plus pembrolizumab 200 mg every 3 weeks.


Trial Purpose
6

US Trial Locations

Clinical trial sites are places such as hospitals or clinics where the trial is being conducted.

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National Trial Reference Number

NCT03776136 Read More at clinicaltrials.gov

What Can You Do Next?

If you would like to learn about this clinical trial or see if you can participate, you can:

Contact Our Trial Info Center

To learn more, call 1-888-577-8839

Discuss With Your Doctor

Print this page or Email it to your doctor to discuss at your next visit

Tip: To help with understanding of some clinical terms used on the page, select an underlined term to see what they mean.

Eligibility

Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.

Condition

The disease, disorder, syndrome, illness, or injury that is being studied. Conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Advanced Melanoma

Age range

18 — no age maximum

Gender(s)

All

Trial Purpose

This study will evaluate the safety and efficacy of combination therapy of lenvatinib (E7080/MK-7902) and pembrolizumab following approximately 2 years of pembrolizumab therapy and approximately 2 years or more lenvatinib therapy in adult participants with unresectable or advanced melanoma who have been exposed to anti-PD-1/L1 agents approved for unresectable or metastatic melanoma. No statistical hypothesis will be tested in this study.

Important information

Participating in a clinical trial is an important decision. Anyone participating in a trial should know as much as possible about what is being studied, what risks are involved and what potential benefits may be gained before deciding to enroll. If you are interested in participating in a clinical trial, please talk to your doctor first.

Trial Locations

    Location
    Status
  • Santa Monica, California, United States, 90404
    Recruiting
  • Park Ridge, Illinois, United States, 60068
    Recruiting
  • Lincoln, Nebraska, United States, 68510
    Recruiting
  • Dallas, Texas, United States, 75246
    Recruiting
  • Chandler, Arizona, United States, 85224
    Recruiting
  • Fairfax, Virginia, United States, 22031-4867
    Recruiting

How to Learn More

When speaking to your doctor, please have the trial reference number available. You can also call 1-888-577-8839 for more information.

Print or email this page.

Trial reference number

A unique identification code given to each clinical trial registered on clinicaltrials.gov.

Leap number

A unique identification code used by the sponsor to identify a specific trial.
Leap-7902-004

Official title

A description of the clinical trial that the trial sponsor and clinicians use to identify a specific trial and its purpose.
A Multicenter, Open-label, Phase 2 Trial to Assess the Efficacy and Safety of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced Melanoma Previously Exposed to an Anti-PD-1/L1 Agent (LEAP-004)

Call 1-888-577-8839 to contact our trial information center

Clinical Trials: Important Information to Consider

There is a lot to consider when deciding whether to participate in a clinical study. Any clinical study includes risks, which the study doctor will review with you. Make sure you understand the risks before participating.