Study on the Effects of EVX-01 and Pembrolizumab in Adults with Advanced Melanoma

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What is this study about?

This clinical trial is focused on studying a type of skin cancer called unresectable or metastatic melanoma. The study is testing a combination of two treatments: EVX-01 and pembrolizumab. Pembrolizumab, also known by its code name MK-3475, is a medication that helps the immune system fight cancer. EVX-01 is a new treatment being tested to see if it can improve the effects of pembrolizumab.

The purpose of the study is to find out if adding EVX-01 to pembrolizumab can help patients with melanoma that cannot be removed by surgery or has spread to other parts of the body. The study will look at how well the combination of these treatments works compared to historical outcomes with pembrolizumab alone. Participants in the study will receive both treatments and will be monitored to see how their cancer responds over time.

During the study, participants will receive pembrolizumab through an infusion, which means the medicine is given directly into a vein. EVX-01 will be given as an injection into a muscle. The study will last for up to 24 months, and participants will have regular check-ups to monitor their health and the progress of their cancer. The study aims to provide more information on the safety and effectiveness of using EVX-01 with pembrolizumab for treating this type of melanoma.

1 initiation of treatment

Upon joining the trial, the patient begins treatment with pembrolizumab. This medication is administered as a solution for infusion through an intravenous route. The dosage is 25 mg/mL, and the frequency and duration of administration are determined by the trial protocol.

2 combination therapy

After the initial assessment of the patient’s response to pembrolizumab, EVX-01 is introduced. This medication is administered as a solution for injection through an intramuscular route. The combination aims to improve the overall response in patients with stable disease or partial response.

3 monitoring and assessment

Throughout the trial, the patient’s response to the treatment is monitored. This includes regular assessments of the disease status using criteria such as RECIST 1.1, which helps in evaluating the size and progression of tumors.

The primary goal is to achieve a complete or partial response in patients with stable disease, and a complete response in those with partial response, over a period of 24 months.

4 safety and side effects

The trial also focuses on the safety of the treatment. The number, type, and severity of any adverse events (AEs) or serious adverse events (SAEs) are recorded and analyzed.

The patient’s immune response to EVX-01 is measured by assessing specific immune cells throughout the dosing period.

5 completion of trial

The trial is expected to conclude by October 31, 2025. At the end of the trial, the overall response rate, progression-free survival, and overall survival are evaluated to determine the efficacy of the treatment combination.

Who Can Join the Study?

The patient or their legal representative must provide written consent to participate in the trial.
The patient must have proper organ function, with tests done within 10 days before starting the trial.
If the patient has HIV, they must be on medication for it and have a well-controlled condition, meaning:
- A CD4+ T-cell count greater than 350 cells/mm³ at the time of screening.
- The HIV virus level must be very low or undetectable for at least 12 weeks before starting the trial.
- The patient must have been on a stable HIV treatment plan for at least 4 weeks before starting the trial.
If the patient has hepatitis B, they must have been on treatment for at least 4 weeks and have an undetectable virus level before starting the trial.
If the patient has a history of hepatitis C, the virus level must be undetectable at screening.
The patient must be at least 18 years old on the day they sign the consent form.
The patient must have a confirmed diagnosis of metastatic or unresectable melanoma at Stage III or IV, which means the cancer has spread and cannot be removed by surgery.
- The patient cannot have a type of melanoma that affects the eye.
- The patient must not have received certain types of cancer treatment called checkpoint inhibitors before.
- The patient must have a sample taken to test for a specific gene change called a BRAF mutation before starting the trial. If they have this mutation, they may have had previous treatment with a BRAF inhibitor.
The patient must have measurable disease, meaning the cancer can be measured by the doctor, even if it was previously treated with radiation.
The patient must be willing to provide a fresh sample of their tumor for further analysis.
The patient must have a good performance status, which means they are able to carry out daily activities with little or no assistance.
Male patients must agree to use birth control and not donate sperm during the treatment and for at least 120 days after the last dose.
Female patients must not be pregnant or breastfeeding and must agree to use birth control if they are of childbearing potential during the treatment and for at least 120 days after the last dose.
The patient must not have any condition that would prevent them from following the trial protocol and schedule.

Who Cannot Join the Study?

Patients who have a type of skin cancer called unresectable or metastatic melanoma cannot participate. This means the cancer cannot be removed by surgery or has spread to other parts of the body.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who do not meet the gender requirements for the study cannot participate. The study is open to both males and females.
Patients who are considered part of a vulnerable population cannot participate. This term refers to groups of people who may need special protection or care, such as children, pregnant women, or those with certain disabilities.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	31.10.2022

Trial locations

Investigated drugs:

EVX-01 is an investigational therapy being studied for its potential to improve the response in patients with melanoma. It is used in combination with another medication to see if it can enhance the treatment effects in patients who have not responded fully to initial treatments.

Pembrolizumab is a medication used to treat certain types of cancer, including melanoma. It works by helping the immune system recognize and attack cancer cells. In this trial, it is used as a standard treatment to evaluate the additional benefits of combining it with EVX-01.

Investigated diseases:

Metastatic malignant melanoma

Melanoma – Melanoma is a type of skin cancer that develops from the pigment-producing cells known as melanocytes. It often appears as a new or changing mole on the skin. Melanoma can grow quickly and has the potential to spread to other parts of the body, making it more serious than other forms of skin cancer. When it becomes unresectable or metastatic, it means the cancer cannot be surgically removed or has spread to other organs. The progression of melanoma can vary, with some cases remaining stable for a period while others may advance rapidly. Early detection and monitoring are crucial for managing the disease effectively.

Trial ID:

2024-512393-10-00

Protocol code:

EVX-01-001

NCT ID:

NCT05309421

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of EVX-01 and Pembrolizumab in Adults with Advanced Melanoma

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