A Randomized, Phase 2/3, Open-Label Study to Investigate the Efficacy and Safety of RP2 in Combination with Nivolumab versus Ipilimumab in Combination with Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients with Metastatic Uveal Melanoma
This research study is investigating new treatments for a specific type of skin cancer that starts in the eye and has spread to other parts of the body. This is called metastatic uveal melanoma. The study compares two different drug combinations for adult patients who haven't had this type of immune checkpoint inhibitor treatment before. One combination uses the experimental drug RP2 alongside Nivolumab (also known as OPDIVO). The other combination uses Ipilimumab (also known as YERVOY) with Nivolumab. Researchers want to find out which of these combinations works better at shrinking the cancer and helping people live longer, while also looking at any side effects the treatments might cause. This is a crucial step towards finding improved treatments for this challenging condition.
At a glance
What is this study about?
This study focuses on a type of cancer called metastatic uveal melanoma. This is a rare form of melanoma that begins in the eye and has unfortunately spread to other parts of the body. For people with this condition, finding effective treatments is very important, and this study aims to explore new options.
The trial is comparing two different treatment approaches. Both approaches involve a drug called Nivolumab, which is an 'immune checkpoint inhibitor.' These types of drugs work by helping your body's own immune system fight cancer cells. The study will look at Nivolumab combined with RP2 (an experimental drug) versus Nivolumab combined with Ipilimumab. Researchers want to see if one combination is better than the other in terms of how well it reduces the cancer and how long people live.
The main goals of the study are to measure how long patients live and how long they live without the cancer getting worse. They will also keep a close eye on any side effects or unwanted reactions to the medications. This is called a 'Phase 2/3' study, meaning it combines two stages of research. Phase 2 tests if a new treatment works and if it's safe. Phase 3 compares a new treatment with an existing one to see if it's better. By running these together, researchers hope to get answers more quickly.
Key takeaways
- This study explores new treatments for metastatic uveal melanoma.
- It compares two drug combinations, both including Nivolumab.
- The goal is to find out which treatment is safer and more effective.
- Participants must be adults who haven't had immune checkpoint inhibitors before.
- Your health will be closely monitored throughout the study.
Who may be eligible?
This study is open to adult patients (age 18 and older) who have metastatic uveal melanoma. This means the melanoma started in the eye and has spread to other parts of the body.
To be considered, you must not have received a type of treatment called an 'immune checkpoint inhibitor' before. These are specific drugs that help your body's immune system fight cancer. The medical team will check your previous treatment history to ensure you meet this requirement.
Both men and women can take part in this study. The doctors will also review your overall health to make sure it's safe for you to participate in the trial.
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 metastatic uveal melanoma (melanoma that started in the eye and has spread)?
- Have you *not* had immune checkpoint inhibitor treatment for your cancer before?
- Are you generally well enough to participate in a clinical study?
What does participation involve?
If you join this study, you will receive one of the two treatment combinations intravenously (through a drip into your arm). You will have regular visits to the clinic for your treatment doses and for various health checks. These checks will include physical exams, blood tests, and scans (like CT or MRI scans) to see how the cancer is responding to the treatment and to monitor for any side effects.
The study will carefully track your progress over time. This includes measuring how long you live and how long the cancer is kept under control. There will be ongoing follow-up appointments even after your main treatment period to monitor your long-term health.
The total duration of your participation in the study will depend on how you respond to the treatment and your overall health, but it will involve a commitment to regular hospital visits and assessments.
Potential risks and benefits
Locations (5)
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedPoland
Common questions
What is 'metastatic uveal melanoma'?
It's a rare type of skin cancer that starts in the eye and has spread to other parts of your body.
What are 'immune checkpoint inhibitors'?
These are drugs that help your body's own immune system find and fight cancer cells.
What drugs are being tested?
The study is comparing RP2 with Nivolumab against Ipilimumab with Nivolumab.
Will I know which treatment I'm getting?
This is an 'open-label' study, which means you and your doctors will know which treatment combination you are receiving.
What does a 'Phase 2/3' study mean?
It means the study is combining two stages of research. Phase 2 checks if a new treatment works and is safe, and Phase 3 compares it to an existing treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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