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Study of AloCelyvir for Patients with Metastatic Uveal Melanoma

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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 a type of cancer called metastatic uveal melanoma, which is a rare form of eye cancer that has spread to other parts of the body. The treatment being tested in this study is called AloCelyvir. AloCelyvir is a special kind of therapy that uses allogenic bone marrow-derived mesenchymal stem cells. These are cells taken from the bone marrow of a donor, which are then modified in a laboratory to help fight cancer.

The purpose of this study is to evaluate how effective AloCelyvir is in treating patients with metastatic uveal melanoma, especially those with cancer that has spread to the liver. Participants in the study will receive the treatment through an intravenous infusion, which means the medicine is given directly into a vein. The study will monitor how the cancer responds to the treatment over time, using specific criteria to measure changes in the size of the cancer.

Throughout the study, participants will have regular visits and examinations to track their progress. The study aims to understand not only how well the treatment works but also how long patients can live without the cancer getting worse. This information will help determine the potential benefits of AloCelyvir for people with metastatic uveal melanoma.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial Treatment
The treatment involves the administration of AloCelyvir, a cell suspension for injection. This medication consists of allogenic bone marrow-derived mesenchymal stem cells that have been modified and expanded outside the body.
The medication is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.
Step 2
Dosage and Frequency
The specific dosage and frequency of the AloCelyvir infusions are determined by the study protocol and will be communicated during the treatment phase.
The treatment is designed to assess the response rate in patients with metastatic uveal melanoma, particularly those with liver disease that can be biopsied.
Step 3
Monitoring and Follow-up
Regular monitoring is conducted to evaluate the effectiveness of the treatment and to observe any side effects. This includes scheduled visits and examinations.
Biopsies of liver metastases are required on day 0 and on day 25, plus or minus 3 days, from the start of the treatment.
Step 4
Outcome Assessment
The primary outcome of the trial is to measure the efficacy of the treatment using the Objective Response Rate (ORR) according to specific criteria.
Secondary outcomes include measuring progression-free survival and overall survival rates at one and two years.

Who can join the trial?

12 criteria

Patients must have a confirmed diagnosis of **metastatic uveal melanoma**, which means the cancer has spread from the eye to other parts of the body, and have measurable disease that cannot be cured with current treatments.
Male participants must agree to use contraception methods during the study and for at least 150 days after the last dose. This includes using a **male condom** and ensuring their partner uses an additional contraceptive method if engaging in sexual activity.
Participants must be willing and able to follow the study protocol, which includes attending scheduled visits and undergoing treatments and examinations.
Participants must have a life expectancy of at least 12 weeks.
Participants must have measurable disease, meaning at least one tumor that can be accurately measured, and at least one liver tumor that can be biopsied.
Participants can have received previous treatments for metastatic disease, except for those listed in the exclusion criteria.
Participants must be 18 years of age or older at the time of entering the study.
Participants must have an **ECOG Performance Status** of 0-1, which indicates they are fully active or have some symptoms but do not require bed rest.
Participants must be capable of giving signed informed consent, which means they understand and agree to the study's requirements and restrictions.
Participants must have normal organ and bone marrow function, which includes specific levels of hemoglobin, neutrophils, platelets, bilirubin, liver enzymes (AST and ALT), and creatinine clearance.
Female participants of childbearing potential must have a negative pregnancy test before receiving study treatment and agree to avoid activities that could result in pregnancy during the study and for 150 days after the last dose.
Female participants must be postmenopausal or have evidence of non-childbearing status, confirmed by a negative pregnancy test and specific hormonal levels or surgical sterilization.

Who cannot join the trial?

5 criteria

Patients who have a different type of cancer than metastatic uveal melanoma. This is a specific type of eye cancer that has spread to other parts of the body.
Patients who do not have a biopsiable liver disease. This means the liver condition must be able to be sampled or tested through a procedure called a biopsy.
Patients who have not tried any systemic line or liver-directed therapy before. These are treatments that affect the whole body or are specifically aimed at the liver.
Patients who are not within the specified age range for the trial. The trial is open to certain age groups only.
Patients who are part of a vulnerable population. This means people who might need special protection or care, such as children or those unable to make decisions for themselves.

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Verified sites

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Hestia Duran I Reynals
L'hospitalet De Llobregat, Spain

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Investigated drugs

AloCelyvir is an investigational therapy being studied for its effectiveness in treating patients with metastatic uveal melanoma, particularly those with liver involvement. This therapy is being evaluated to see how well it can help reduce the size of tumors or slow their growth in patients who have not responded to other treatments.

Allogenic Bone Marrow-Derived Mesenchymal Stem Cells Transduced With Icovir-5, Ex Vivo Expanded

What is already known about the treatment

AloCelyvir – AloCelyvir is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials, specifically for its effectiveness in treating metastatic uveal melanoma, a type of eye cancer that has spread to other parts of the body. The medication is designed to target and destroy cancer cells, although the exact molecular mechanism is still under investigation. It falls under the category of experimental cancer therapies, as it is not yet widely recognized in medical literature outside of clinical research settings.

Investigated diseases

Metastatic Uveal Melanoma – This is a type of cancer that originates in the uveal tract of the eye, which includes the iris, ciliary body, and choroid. It is characterized by the spread of melanoma cells from the eye to other parts of the body, most commonly the liver. The disease progresses as the cancerous cells invade and grow in these new locations, often leading to the formation of tumors. Symptoms may vary depending on the organs affected by the metastasis, but can include vision changes, liver enlargement, or abdominal discomfort. The progression of the disease can be monitored through imaging and other diagnostic tools to assess the growth and spread of tumors.