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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Consorcio Hospital General Universitario De Valencia	Castello De La Plana	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hmxjxtui Ugijubblblflz Mhkysnb Dv Vgyketlluf	Santander	Spain
Idpqajkf Civxfu Djrglcejmddtnneyc	L'hospitalet De Llobregat	Spain
Ffrcfqynt Pwjv Lu Itedrgorqinrq Bihqroqqt Dxt Hjufziqv Utgonrejaqsde Lh Pzl	Madrid	Spain
Hgrnvspo Vjta dlggixzl	Barcelona	Spain
Hpjoswwl Udejdfwgblrqp do A Caopvn	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	30.01.2025

Trial locations

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.

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 ID:

2024-514163-26-00

Protocol code:

GEM 2303

Trial Phase:

Therapeutic exploratory (Phase II)

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

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