Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

Phase I/II stUdy of ALoCelyvir in patientS with mEtastaticUveal Melanoma (PULSE-UM)

This study, called PULSE-UM, is for people who have uveal melanoma (a type of eye cancer) that has spread to other parts of their body. Researchers are testing a new treatment called AloCelyvir to see how well it works and if it's safe. It's an early stage study, meaning it's one of the first times this treatment is being used in a larger group of people. Doctors will be checking to see if tumours shrink in size and how long people live after receiving the treatment. They will also look at how long people live without their cancer getting worse, and survival rates over one and two years. Eligible participants must be 18 years or older.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL

Enrolment target

Start

06 Sep 2024

mEtastatic Uveal Melanoma

What is this study about?

This study, called PULSE-UM, is looking into a new treatment for a specific type of cancer. The cancer being studied is called uveal melanoma, which starts in the eye but has spread to other parts of the body. When cancer spreads, it's called metastatic. The new treatment being investigated is named AloCelyvir.

This study is in its early stages, known as Phase I and Phase II. This means that researchers are trying to find out a few key things. Firstly, they want to understand if AloCelyvir can actually shrink the cancer or stop it from growing. They will also be carefully watching for any side effects to see how safe the treatment is. These early phases are important steps in developing new medicines.

To figure out if the treatment is working, doctors will measure the size of the tumours. They will also look at how long people live after starting the treatment, and how long people live without their cancer getting worse. They'll also check survival rates after one and two years to get a clearer picture of the treatment's impact.

Key takeaways

Tests a new treatment (AloCelyvir) for metastatic uveal melanoma.
Aims to see if tumours shrink and how long patients live.
Open to adults aged 18 and over, both men and women.
Involves regular visits and assessments to monitor your health.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be able to join this study, you need to meet a few simple requirements.

First, you must be at least 18 years old. There is no upper age limit, so people of any age over 18 can take part. Both men and women are welcome to join the study.

The main medical requirement is that you have uveal melanoma (a type of eye cancer) that has spread to other parts of your body. Doctors will check your medical history to make sure you fit all the necessary criteria for the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have uveal melanoma (a type of eye cancer)?
Has your uveal melanoma spread to other parts of your body?
Are you able to attend regular appointments for the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the new treatment, AloCelyvir. The study team will explain exactly how you'll receive the treatment and how often. You will have regular appointments at the hospital or clinic. During these visits, doctors and nurses will carry out various checks and tests. These might include scans to measure your tumours, blood tests, and discussions about how you're feeling and any side effects you might be having.

The study will continue for a period, which will be fully explained to you. Even after you stop receiving the treatment, you might have follow-up appointments to see how you are doing in the longer term. The research team will provide a detailed schedule of all visits and assessments.

Potential risks and benefits

Taking part in an early-stage study like this means you might be one of the first people to receive a new treatment that could potentially help with your condition, although there's no guarantee it will work for everyone. Your health will be closely monitored, and you'll contribute to scientific knowledge that could help others in the future. However, new treatments can also have side effects, and some might be serious or unexpected. The study team will explain all known or potential risks to you. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What kind of cancer is this study for?

This study is for a type of eye cancer called uveal melanoma that has spread to other parts of the body.

What is AloCelyvir?

AloCelyvir is the new treatment being tested in this study.

What does 'early stage study' mean?

It means this is one of the first times this new treatment is being given to a group of people to see how safe it is and if it works.

Will my cancer definitely get better if I join?

There's no guarantee the treatment will work for everyone, but the study aims to find out if it can help shrink tumours or stop them from growing.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your ongoing medical care.