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Study on the Effectiveness of Enfortumab Vedotin and Pembrolizumab for Patients with Advanced Melanoma

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying advanced melanoma, a type of skin cancer that has spread to other parts of the body. The study will test the effectiveness and safety of a combination of two treatments: enfortumab vedotin and pembrolizumab. Enfortumab vedotin, also known by its code names ASG22CE and ASP7465, is a type of medication called an antibody-drug conjugate, which is designed to target and kill cancer cells. Pembrolizumab, sometimes referred to by its code names Lambrolizumab or MK-3475, is a medication that helps the immune system fight cancer cells.

The purpose of this study is to evaluate how well these two medications work together in treating patients with advanced melanoma who have already received other treatments. Participants in the study will receive these medications through an intravenous infusion, which means the medicine is given directly into a vein. The study will last for up to 24 months, during which time participants will be monitored for their response to the treatment and any side effects they may experience.

Throughout the study, researchers will assess various outcomes, such as how many patients experience a reduction in their cancer, how long patients live without their cancer getting worse, and the overall survival time. The study will also look at the safety of the treatment combination by tracking any adverse events, which are unwanted effects that may occur during the study. The goal is to gather information that could lead to better treatment options for people with advanced melanoma.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of advanced melanoma and ensuring adequate organ function.

    A biopsy may be required to provide a sample of the tumor tissue. This is necessary if no recent samples are available.

  2. Step 2

    Treatment initiation

    The treatment involves two medications: enfortumab vedotin and pembrolizumab. Both are administered as solutions for infusion through a vein (intravenous infusion).

    The specific dosage and frequency of administration will be determined by the study protocol and the healthcare team.

  3. Step 3

    Treatment monitoring

    Regular monitoring is conducted to assess the response to treatment. This includes imaging tests such as CT scans or MRIs to evaluate tumor size and progression.

    The healthcare team will also monitor for any side effects or adverse reactions to the medications.

  4. Step 4

    Response evaluation

    The primary goal is to measure the objective response rate, which is the percentage of patients with a significant reduction in tumor size.

    Secondary goals include assessing progression-free survival, overall survival, and the clinical benefit rate.

  5. Step 5

    End of treatment

    The treatment continues until there is evidence of disease progression or unacceptable side effects occur.

    After the treatment ends, the time until the start of any new treatment is recorded as the treatment-free interval.

  6. Step 6

    Follow-up

    Follow-up assessments are conducted to monitor long-term outcomes and any delayed side effects.

    The study aims to gather data on the duration of response and treatment-free survival.

Who can join the trial?

9 criteria

  • Participants must be at least 18 years old and have a confirmed diagnosis of **unresectable** or **metastatic melanoma**. This means the melanoma cannot be removed by surgery or has spread to other parts of the body.
  • Participants need to have **adequate organ function**. This means their organs, like the liver and kidneys, are working well enough to handle the study treatment.
  • Participants must have **measurable disease**. This means the cancer can be measured by doctors to see if it is getting better or worse.
  • Male participants must agree to use **contraception** during the study and for a certain time after the last dose of treatment. They should also not donate sperm during this time.
  • Female participants must not be pregnant or breastfeeding. If they can have children, they must use contraception for a specific time after the last dose of treatment.
  • Participants must have had previous treatment for advanced melanoma and shown that the treatment did not work. This includes treatment with **anti-PD-1/L1** medications, which help the immune system fight cancer.
  • Participants should have recovered from any side effects of previous cancer treatments to a certain level. Some side effects, like hormone-related issues that are treated with medication, are acceptable.
  • Participants must have an **ECOG performance status** of 0 to 1. This is a scale that measures how well they can perform daily activities.
  • Participants need to provide a sample of their tumor tissue, either from a previous treatment or a new biopsy, if it is safe to do so.

Who cannot join the trial?

3 criteria

  • Patients who have a different type of cancer other than advanced melanoma cannot participate. Advanced melanoma is a serious form of skin cancer that has spread to other parts of the body.
  • Patients who are under the age of 18 or over the age of 65 are not eligible to join the study.
  • Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, are not allowed to participate.
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Investigated drugs

  • Enfortumab Vedotin

    is a medication used in this study to treat advanced melanoma. It works by targeting and binding to specific cancer cells, delivering a substance that can help kill these cells. This medication is being tested to see how effective it is when used in combination with another treatment.

  • Pembrolizumab

    is another medication used in this study. It is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. By enhancing the immune response, pembrolizumab aims to slow down or stop the growth of cancer cells in patients with advanced melanoma.

What is already known about the treatment

  • Enfortumab Vedotin

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating advanced melanoma. It is not yet widely used in standard medical practice but shows promise in ongoing research. Enfortumab Vedotin works by targeting cancer cells with a specific protein and delivering a toxic agent to kill these cells. It is classified as an antibody-drug conjugate, combining a monoclonal antibody with a cytotoxic drug.

  • Pembrolizumab

    This medication is also administered intravenously and is already approved for use in various cancers, including melanoma. It is being studied in combination with Enfortumab Vedotin for advanced melanoma. Pembrolizumab works by blocking a protein called PD-1, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor, enhancing the body's immune response against cancer.

Investigated diseases

Advanced Melanoma – Advanced melanoma is a severe form of skin cancer that occurs when the pigment-producing cells known as melanocytes grow uncontrollably. It often begins as a mole that changes in size, shape, or color and can spread to other parts of the body, including lymph nodes and internal organs. As the disease progresses, it may cause symptoms such as skin lesions, swollen lymph nodes, and organ dysfunction. The progression of advanced melanoma can vary, with some cases spreading rapidly while others may remain stable for a period. It is typically more challenging to treat once it has spread beyond the skin. The disease requires careful monitoring to assess changes in its progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514163-26-00Protocol codeGEM 2303Estimated enrolment60 patientsSponsorGrupo Espanol Multidisciplinar De Melanoma

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