An open-label, randomized, Phase 3 clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable, or metastatic (advanced) melanoma
This research study is investigating new treatment options for advanced melanoma, a type of skin cancer that has spread or cannot be removed by surgery. If you have advanced melanoma and haven't started treatment yet, this study might be for you. Researchers are comparing a new combination of two drugs, IO102-IO103 and a well-known drug called pembrolizumab (KEYTRUDA), against pembrolizumab alone. The main goal is to see if the new combination can better slow down or stop the cancer's growth. They will also look at how much the tumors shrink and how long people live. This is a 'Phase 3' study, meaning it's a key step to see if this new treatment works well and is safe.
At a glance
What is this study about?
This clinical trial is designed for people who have advanced melanoma that has not been treated with medication before. 'Advanced' means the cancer is either unresectable (can't be removed by surgery) or metastatic (has spread to other parts of the body).
The main idea behind this study is to compare a new treatment approach with an existing one. Currently, pembrolizumab (KEYTRUDA) is a standard treatment for advanced melanoma. In this study, some participants will receive pembrolizumab on its own, like current treatment. Other participants will receive pembrolizumab alongside two new investigational drugs called IO102 and IO103. The researchers want to find out if adding IO102-IO103 to pembrolizumab is more effective at controlling the cancer.
The study focuses on several important measures. The most important is 'progression-free survival,' which means how long someone lives without their cancer getting worse or growing. They will also look at how many people see their tumours shrink ('overall response rate') and how long people live overall. By carefully comparing these outcomes between the two treatment groups, the researchers hope to determine if this new combination could be a better treatment option for future patients.
Key takeaways
- Tests a new combination of drugs (IO102-IO103 + KEYTRUDA) for advanced melanoma.
- Compares the new combination to KEYTRUDA alone.
- For adults with previously untreated, advanced melanoma.
- Aims to see if the new combination can better stop cancer growth.
- Participation involves regular clinic visits and health checks.
- Your choice to join or leave the study is entirely yours.
Who may be eligible?
To be considered for this study, you must be an adult, aged 18 or older. Both men and women can participate in the trial.
Key conditions for joining are that you have advanced melanoma which either cannot be surgically removed or has spread to other parts of your body. Importantly, you should not have received any previous treatment (like other medications or radiation, but surgery is okay if it didn't remove all the cancer) for this advanced melanoma.
There might be other specific health requirements or conditions that would prevent you from taking part, which your study doctor will discuss with you in detail. This ensures that the study is safe and appropriate for everyone involved.
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?
- Have you been diagnosed with advanced melanoma?
- Has your melanoma not been treated with medication before?
- Is your melanoma either unresectable (cannot be removed) or metastatic (has spread)?
- Are you able to attend regular clinic appointments for treatment and check-ups?
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 might receive the new combination of IO102-IO103 plus pembrolizumab, or you might receive pembrolizumab alone. You won't be able to choose which group you are in, and neither will your doctor.
Your involvement will include regular visits to the hospital or clinic. During these visits, you will have various tests and assessments, such as blood tests, scans (like CT or MRI scans) to check your cancer, and physical examinations. These are important for monitoring your health and how the treatment is working. The study drugs will be given directly into your vein (as an infusion) at specific times, which your study team will schedule.
You'll be followed closely throughout the treatment period and even after the main treatment has finished, to monitor your health in the long term. The total duration of your participation could vary, but the doctor will explain the expected timeline for treatments, follow-up appointments, and how long they will continue to check on your health.
Potential risks and benefits
Locations (10)
- —UnverifiedHungary
- —UnverifiedDenmark
- —UnverifiedPoland
- —UnverifiedItaly
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedGermany
- —UnverifiedCzechia
- —UnverifiedNetherlands
Common questions
What is advanced melanoma?
Advanced melanoma means a type of skin cancer that has grown and spread to other parts of the body, or cannot be fully removed by surgery.
What is the new treatment combination?
The new treatment combination being tested involves two drugs called IO102-IO103, used together with an existing medication named pembrolizumab (KEYTRUDA).
What does 'Phase 3' mean for a clinical trial?
Phase 3 means this is a large study to confirm if a new treatment is effective and safe compared to current treatments, often involving many participants.
Will I know which treatment I'm receiving?
No, you will be randomly assigned to a treatment group, and neither you nor your doctor will usually know if you're getting the new combination or the existing treatment alone.
What if I decide I don't want to continue?
You can leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.