Active not recruitingPHASE2INTERVENTIONAL

Trametinib With or Without GSK2141795 in Treating Patients With Metastatic Uveal Melanoma

This research study is for people with uveal melanoma that has spread to other parts of the body. Doctors want to find out if a medicine called trametinib works better on its own or when combined with another drug, GSK2141795. Both medicines aim to stop cancer cells from growing. Participants will be split into two groups: one receiving trametinib only, and the other receiving both trametinib and GSK2141795. The study will compare how long people stay well without their cancer getting worse, how long they live, and if the treatments cause side effects. It's a 'Phase 2' study, meaning researchers are looking at how well the treatments work and if they are safe.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

National Cancer Institute (NCI)

Enrolment target

Start

21 Nov 2013

Estimated completion

02 Jul 2026

Recurrent Uveal Melanoma Stage IV Uveal Melanoma AJCC v7

What is this study about?

This study is designed for individuals diagnosed with uveal melanoma that has spread from the eye to other parts of the body, which is called metastatic uveal melanoma. Doctors are trying to find the most effective way to treat this type of cancer. They are specifically looking at two medicines: trametinib and GSK2141795. Both of these drugs are designed to interfere with processes that cancer cells need to grow and spread. By blocking these processes, the hope is to slow down or stop the cancer.

Participants in this study will be randomly assigned to one of two groups. One group will receive trametinib on its own, and the other group will receive trametinib combined with GSK2141795. The main goal is to compare how well each treatment works. Researchers will be looking at how long people live without their cancer getting worse, how long they live overall, and how many people see their cancer shrink or disappear. They will also carefully monitor any side effects to understand the safety of each treatment.

By comparing these two treatment approaches, the study aims to gather important information. This will help doctors understand whether adding GSK2141795 to trametinib makes the treatment more effective or safer for people with this specific type of metastatic uveal melanoma. The results could help guide future treatment decisions for patients.

Key takeaways

This study is for people with advanced uveal melanoma.
It compares two medicines: trametinib alone vs. trametinib with GSK2141795.
The goal is to see which treatment works better and is safer.
Participants will be randomly assigned to one of two treatment groups.
Regular visits, blood tests, and scans will monitor your health and the cancer's response.
You can leave the study at any time if you wish.

Who may be eligible?

This study is for adults aged 18 or older who have uveal melanoma that has spread to other parts of their body. You need to have had your diagnosis confirmed by a doctor.

To join, your overall health must be reasonably good, meaning you can carry out most daily activities, and doctors expect you to live for more than three months. You also need to be able to swallow medicines whole and have a healthy enough digestive system to absorb them properly. Your blood test results, such as white blood cells, red blood cells, and platelets, need to be within a certain range.

Importantly, you shouldn't have received specific types of cancer treatments for your advanced uveal melanoma before joining this study. Some local treatments, like those targeting a specific spot, are allowed if they were done at least 21 days before the study starts. Any side effects from previous treatments should also be mild or gone.

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.

I am 18 years old or older.
I have uveal melanoma that has spread to other parts of my body.
My cancer diagnosis has been confirmed by a doctor.
My general health is good enough for me to carry out most daily activities.
I have not had certain types of previous treatments for advanced uveal melanoma.
I am able to swallow tablets and have a healthy digestive system.

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be randomly assigned to one of two treatment groups, like flipping a coin. You won't get to choose which group you're in. One group will take trametinib by mouth once a day, and the other group will take both trametinib and GSK2141795 by mouth once a day. You will take these medicines for a 4-week cycle, and these cycles will repeat as long as the treatment is working and you are not experiencing severe side effects.

Throughout the study, you will have regular visits to the clinic for check-ups, blood tests, and scans to see how the treatment is affecting your cancer and your overall health. Researchers will also collect samples for further lab tests to understand how the medicines are working. After you finish taking the study medication, you'll have a follow-up visit four weeks later, and then check-ups every 12 weeks after that for a longer period to monitor your health.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as receiving new treatments that are not yet widely available, and your health will be closely monitored. However, there are also potential risks involved. The medicines being studied may cause side effects, some of which could be serious, and the treatment may not work for everyone. You will be told about all known potential side effects before you decide to join. It's crucial to remember that your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (7)

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

Emory University Hospital/Winship Cancer Institute
Verified postcode
Atlanta, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Verified postcode
New York, United States
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States
Vanderbilt University/Ingram Cancer Center
Verified postcode
Nashville, United States
M D Anderson Cancer Center
Verified postcode
Houston, United States
Institut Curie Paris
Verified postcode
Paris, France
The University of Liverpool
Verified postcode
Liverpool, United Kingdom

Common questions

What is uveal melanoma?

Uveal melanoma is a rare type of cancer that forms in certain cells of the eye. This study is for when it has spread to other parts of the body.

What are trametinib and GSK2141795?

These are medicines that are designed to stop cancer cells from growing and spreading by blocking specific processes within the cells.

Will I know which treatment I am getting?

No, you will be randomly assigned to one of the two groups, and you won't know if you're getting trametinib alone or with GSK2141795. This helps ensure fair results.

What happens if the treatment stops working for me?

The study outline mentions that if your cancer starts to grow again while on trametinib alone, you might be able to try the combination treatment. However, the study notes that this crossover option may no longer be available.

How long will I be in the study?

You will take the study medication for as long as it's working and your side effects are manageable. After stopping the treatment, you will have follow-up appointments for quite some time to monitor your health.