Leap 7902-003

For patients with Advanced Melanoma as First-Line Intervention

Safety and Efficacy Study of Pembrolizumab Combined With Lenvatinib as First-line Intervention in Adults With Advance Melanoma

The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) as first-line treatment in adults with no prior systemic therapy for their advance melanoma. The primary study hypotheses are that: 1) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and 2) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Overall Survival (OS). For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

Status:

Recruiting

Phase 3 Icon

Trial Phase

The investigational drug is being studied in a large group of patients to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the investigational drug to be used safely.

Eligibility

About the Trial

All patients who enroll in the trial will receive medication while on the study.

  • 50% will receive pembrolizumab by IV along with lenvatinib capsules by mouth
  • 50% will receive pembrolizumab by IV along with placebo capsules by mouth

Neither you nor the study doctor will know what you are getting. In case of a health emergency, the study doctor can find out.

Trial Purpose
10

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

NCT03820986 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.
Malignant Melanoma

Age range

18 — no age maximum

Gender(s)

All

Trial Purpose

The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) as first-line treatment in adults with no prior systemic therapy for their advance melanoma. The primary study hypotheses are that: 1) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and 2) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Overall Survival (OS). For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

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
  • San Francisco, California, United States, 94115
    Recruiting
  • Aurora, Colorado, United States, 80045
    Recruiting
  • Chapel Hill, North Carolina, United States, 28512
    Recruiting
  • Los Angeles, California, United States, 90025
    Recruiting
  • Niles, Illinois, United States, 60714
    Recruiting
  • Billings, Montana, United States, 59102
    Recruiting
  • Portland, Oregon, United States, 97239
    Recruiting
  • Fairfax, Virginia, United States, 22031-4867
    Recruiting
  • New Haven, Connecticut, United States, 06511
    Recruiting
  • San Francisco, California, United States, 94115
    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-7902-003

Official title

A description of the clinical trial that the trial sponsor and clinicians use to identify a specific trial and its purpose.
A Phase 3 Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) and Lenvatinib (E7080/MK-7902) Versus Pembrolizumab Alone as First-line Intervention in Participants With Advanced Melanoma (LEAP-003)

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.