A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study of Adjuvant MK-7684A (Vibostolimab with Pembrolizumab) Versus Adjuvant Pembrolizumab in Participants with High-risk Stage II-IV Melanoma (KEYVIBE-010)
This research study, called KEYVIBE-010, is for people in the UK with a type of skin cancer called melanoma. Specifically, it's for those with melanoma that has been removed but has a high chance of coming back or spreading. The study wants to see if a new combination treatment, called MK-7684A (which includes Vibostolimab and Pembrolizumab), is better than Pembrolizumab alone at stopping the cancer from returning. Pembrolizumab, also known as KEYTRUDA, is an existing treatment for melanoma. Researchers will also look at how patients feel and their quality of life, as well as any side effects. This is a large study (Phase III) to confirm if the new treatment works and is safe.
At a glance
What is this study about?
This clinical trial is looking at a new way to treat melanoma, which is a serious type of skin cancer. After melanoma has been treated, for example by surgery, there's always a chance it could come back or spread to other parts of the body. This study focuses on people whose melanoma has a higher risk of returning.
The main goal of this study is to compare a new combination treatment, called MK-7684A (which combines two medicines, Vibostolimab and Pembrolizumab), with an existing treatment, Pembrolizumab (also known as KEYTRUDA) alone. Both of these treatments help your body's immune system fight cancer. Researchers want to find out if the new combination can prevent the melanoma from coming back for longer than the existing treatment.
Alongside checking if the cancer returns, the study will also monitor other important things. This includes how long people live, if the cancer spreads to distant parts of the body, and how the treatments affect daily life and overall well-being. They'll also carefully track any side effects to understand how safe each treatment is. This is a 'Phase 3' study, which means it's one of the final steps to see if a new treatment should become widely available.
Key takeaways
- Tests a new combination treatment for high-risk melanoma.
- Compares it against an existing melanoma treatment (KEYTRUDA).
- Aims to stop the cancer from returning.
- Also monitors quality of life and side effects.
- Involves regular hospital visits and check-ups.
- Participants are adults with specific melanoma types.
Who may be eligible?
To join this study, you would generally need to be an adult, 18 years of age or older, and your healthcare team would need to confirm that you have a specific type of melanoma. This would be melanoma that has a high chance of returning after initial treatment.
Both men and women can take part. There will be other specific medical checks and requirements to make sure the study treatments are suitable and safe for you. Your doctor or the study team will go through all the details with you carefully.
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 melanoma that your doctor considers 'high-risk' (meaning it has a higher chance of coming back)?
- Are you able to attend regular hospital appointments for treatment and check-ups?
- Are you comfortable with the idea of not knowing which treatment you are receiving?
What does participation involve?
If you decide to take part, you would be assigned to one of two treatment groups by chance, like flipping a coin. Neither you nor your doctor would know which treatment group you are in (this is called 'double-blind'). You would receive either the new combination treatment (Vibostolimab with Pembrolizumab) or Pembrolizumab alone as an infusion, given directly into your vein. You would have regular hospital visits for these treatments, check-ups, blood tests, and scans to monitor your health and the cancer.
Throughout the study, you'll be asked to complete questionnaires about your quality of life, which helps researchers understand how the treatment is affecting your daily well-being. The total duration of your active treatment will be carefully planned, and after treatment ends, there will be a follow-up period to continue monitoring your health over several years. You would need to commit to attending all scheduled appointments.
Potential risks and benefits
Locations (9)
- —UnverifiedAustria
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedBelgium
- —UnverifiedSweden
- —UnverifiedGermany
- —UnverifiedIreland
- —UnverifiedPoland
Common questions
What is melanoma?
Melanoma is a serious type of skin cancer that develops from pigment-producing cells. It can spread if not treated early.
What is KEYTRUDA and Pembrolizumab?
KEYTRUDA is the brand name for a medicine called Pembrolizumab. It helps your body's own immune system fight cancer.
What is a 'Phase 3' study?
A Phase 3 study is a large study that compares a new treatment to an existing one or a placebo, to see if it's better and safe enough to be approved for wider use.
Will I know which treatment I'm getting?
No, this is a 'double-blind' study, meaning neither you nor your doctor will know which specific treatment you are receiving. This helps make the study fair.
What does 'recurrence-free survival' mean?
This measures how long a person lives without their cancer coming back or getting worse after treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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