Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared with Investigator’s Choice in HLA-A*0201 Positive Patients with Previously Untreated Advanced Uveal Melanoma

This research study, called a Phase II trial, is investigating a new treatment named IMCgp100 for a type of cancer called advanced uveal melanoma, which starts in the eye and has spread. Patients in this study have not received treatment for their advanced melanoma before. The study will openly compare IMCgp100 with other standard treatments chosen by the doctor. The main goal is to see if IMCgp100 helps people live longer and to understand its safety. Researchers will also look at side effects, how well the treatments shrink the cancer, and how patients' quality of life changes. Only patients with a specific genetic marker (HLA-A*0201) are included.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Immunocore Limited

Enrolment target

Start

07 Nov 2024

Previously untreated advanced uveal melanoma (UM)

What is this study about?

This research study is about finding better ways to treat a serious type of cancer called advanced uveal melanoma (UM). Uveal melanoma is a rare cancer that starts in the eye, and 'advanced' means it has spread to other parts of the body. When current treatments aren't enough, doctors and researchers look for new options.

This study is comparing a new drug, called IMCgp100 (also known as KIMMTRAK), with treatments that doctors usually recommend. It's a 'Phase II' study, which means researchers are checking if the new drug is safe and if it shows promise in treating the cancer, before it can be considered for wider use. They want to find out if it helps people live longer than current treatments and keep a close eye on any side effects.

The study involves people whose advanced uveal melanoma hasn't been treated yet. Participants need to have a specific genetic marker, like a 'cellular ID' called HLA-A*0201. This is important because the new drug, IMCgp100, is designed to work specifically in people with this marker. By taking part, patients could help researchers learn more about how to treat this condition, potentially leading to new and more effective medicines in the future.

Key takeaways

This study evaluates a new drug (KIMMTRAK) for advanced uveal melanoma.
It's for patients whose advanced melanoma hasn't been treated yet.
Participants must have a specific genetic marker called HLA-A*0201.
The study compares the new drug with existing standard treatments.
The main goals are to check safety and how long patients live.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult, 18 years or older, and can be male or female. Your doctor will need to check if you have a specific marker in your blood called HLA-A*0201. This is a common genetic factor.

Another important requirement is that you have advanced uveal melanoma that has spread to other parts of your body, and you haven't received any treatment for this advanced stage of the disease yet. This study is specifically for people in this situation.

There will be other health checks and tests to make sure that the study treatment is suitable and safe for you. Your medical team will go through all the details to confirm if you meet the specific criteria to take part.

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 advanced uveal melanoma that has spread?
Have you *not* had treatment for your advanced uveal melanoma yet?
Has your doctor confirmed you have the HLA-A*0201 genetic marker?
Are you able to attend regular hospital visits and undergo medical tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to receive either the new drug (KIMMTRAK) or one of the standard treatments for advanced uveal melanoma, such as YERVOY, KEYTRUDA, or DACARBAZINE. This is like flipping a coin, so neither you nor your doctor chooses which group you're in. All treatments are given as an infusion, meaning they are delivered directly into your bloodstream, usually through a drip.

You will need to attend regular visits to the hospital or clinic for your treatment and various tests. These tests will include blood samples, physical exams, and possibly scans to check how you are responding to the treatment and to monitor for any side effects. Researchers will also ask about your general well-being and quality of life regularly.

The study will continue for as long as your treatment is benefiting you or until side effects make it necessary to stop. After you finish the main treatment phase, there will be follow-up appointments to track your health and long-term progress. The total duration of your participation could vary greatly depending on how you respond to the treatment.

Potential risks and benefits

Taking part in a clinical trial means you might get access to a new treatment that isn't widely available yet, which could potentially help your condition. However, there's no guarantee it will work for you, and it might not be better than existing treatments. All medications, including the ones in this study, can have side effects, which could be mild or more serious. The research team will monitor you closely for any issues and will explain all known risks. Remember, deciding to be part of a study is entirely your choice, and you can withdraw at any time without affecting your usual medical care.

Locations (5)

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

—
Unverified
Spain
—
Unverified
Italy
—
Unverified
Belgium
—
Unverified
France
—
Unverified
Poland

Common questions

What is uveal melanoma?

Uveal melanoma is a rare type of cancer that starts in the eye. 'Advanced' means it has spread to other parts of the body.

What does 'Phase II' mean?

Phase II means this is an early stage of testing a new treatment. Researchers are looking closely at how safe it is and if it shows good signs of working before testing it on more people.

What is IMCgp100 (KIMMTRAK)?

IMCgp100, also called KIMMTRAK, is a new drug being tested in this study. It's designed to specifically target cancer cells in people with a certain genetic marker.

What does HLA-A*0201 mean?

HLA-A*0201 is a specific genetic marker that some people have. The new drug in this study is designed to work in people who have this marker.

Can I choose which treatment I receive?

No, in this study, you'll be randomly assigned to receive either the new drug or one of the standard treatments. This helps ensure fair testing of the new treatment.