Active not recruitingPHASE3INTERVENTIONAL

A Clinical Study of Intismeran Autogene (V940) Plus Pembrolizumab in People With High-Risk Melanoma (V940-001)

This research study is investigating a new treatment called Intismeran Autogene, which is a personalised therapy, alongside an existing treatment called Pembrolizumab. The study is for people who have had high-risk melanoma removed by surgery. Researchers want to find out if this combination treatment is safe and more effective at preventing the melanoma from returning compared to receiving Pembrolizumab alone. They are hoping to understand if the new personalised therapy, when added to Pembrolizumab, offers a better chance of keeping cancer away for longer in patients who have already undergone surgery for their melanoma. This is a Phase 3 trial, meaning it's in the later stages of testing before potential approval.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

1,089

Start

19 Jul 2023

Estimated completion

26 Sep 2030

Melanoma

What is this study about?

This study is designed for individuals who have undergone surgery for a type of skin cancer called melanoma, specifically when it's considered 'high-risk.' High-risk means there's a greater chance of the cancer coming back. The main goal is to see if a new, personalised treatment called Intismeran Autogene, when given with an existing medication called Pembrolizumab, can help prevent the melanoma from returning after surgery. Pembrolizumab is a type of immunotherapy that works by helping your own immune system fight cancer.

Intismeran Autogene is special because it's a 'personalised vaccine.' This means it's tailored to each individual's cancer. It aims to teach your body's immune system to recognise and attack any remaining melanoma cells, hopefully stopping the cancer from growing back. By combining this personalised approach with Pembrolizumab, researchers are hoping to give patients a stronger and more targeted defence against their cancer.

The study will compare the effects of receiving both Intismeran Autogene and Pembrolizumab against receiving Pembrolizumab on its own. This comparison will help researchers determine if adding the personalised treatment offers a significant benefit in preventing melanoma recurrence and if it's safe for patients. The insights gained from this study are crucial for developing better treatments and improving outcomes for people with high-risk melanoma.

Key takeaways

Tests a personalised treatment for high-risk melanoma.
Combines a new treatment with an existing immunotherapy.
Aims to prevent cancer from returning after surgery.
Compares the new combination against existing treatment.
Focuses on safety and effectiveness.
Participation involves regular clinic visits and monitoring.

Who may be eligible?

To be considered for this study, you must have had melanoma skin cancer that was completely removed by surgery. This melanoma needs to be classified as 'high-risk,' specifically Stage IIB, IIC, III, or IV. It's important that you haven't had any other cancer treatments for your melanoma previously, beyond the surgery itself. Also, at the time you agree to join the study, doctors must confirm that you are currently free of cancer, meaning no disease is detectable after surgery. There are also specific timeframes involved; for instance, no more than 13 weeks should have passed between your last surgery to remove the cancer and when you would start the study medication.

There are certain situations that would prevent someone from joining the study. For example, if you have melanoma in your eye or on mucous membranes (like inside the mouth or nose), or if your cancer has spread to other parts of your body and cannot be removed by surgery, you wouldn't be eligible. Individuals with certain heart conditions, or those who have had other cancer treatments or another type of cancer that has spread or needed treatment in the last three years, would also not be able to participate. Also, if you've had a severe reaction to medicines similar to those used in the study, or haven't fully recovered from major surgery, you would likely be excluded.

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.

Have you had high-risk melanoma skin cancer that was completely removed by surgery?
Have you not had any other cancer treatments for your melanoma yet?
Are you currently free of cancer after your surgery?
Is it less than 13 weeks since your final surgery for melanoma?
Do you have a different type of melanoma, like in your eye or on mucous membranes?
Have you had heart failure in the last 6 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new personalised treatment (Intismeran Autogene) along with Pembrolizumab, or Pembrolizumab on its own. Your treatment will be decided randomly, like flipping a coin. You will have regular visits to the clinic for assessments, which will include physical examinations, blood tests, and scans to monitor your health and the cancer. These visits will also be for receiving your study medications. The study will involve a treatment period, during which you'll receive the medications, followed by a period where doctors will keep track of your health over time to see how you're doing. The exact number of visits, tests, and the total duration of your involvement will be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new, experimental treatment (Intismeran Autogene) that could potentially reduce the risk of your melanoma returning. However, there's no guarantee of benefit, as this is a research study. Like all medications, the treatments in this study may have side effects, which can range from mild to serious, and these will be thoroughly explained by the study team. You have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (165)

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

Highlands Oncology Group ( Site 1943)
Verified postcode
Springdale, United States
UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1918)
Verified postcode
Los Angeles, United States
UCSF Medical Center at Mission Bay ( Site 1929)
Verified postcode
San Francisco, United States
Yale-New Haven Hospital-Yale Cancer Center ( Site 1933)
Verified postcode
New Haven, United States
Orlando Health Cancer Institute ( Site 1937)
Verified postcode
Orlando, United States
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center ( Site 1945)
Verified postcode
Tampa, United States
Winship Cancer Institute of Emory University ( Site 1940)
Verified postcode
Atlanta, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 1950)
Verified postcode
Marietta, United States
University of Iowa-Holden Comprehensive Cancer Center ( Site 1935)
Verified postcode
Iowa City, United States
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Melanoma ( Site 1912)
Verified postcode
Baltimore, United States
Massachusetts General Hospital ( Site 1927)
Verified postcode
Boston, United States
Beth Israel Deaconess Medical Center ( Site 1957)
Verified postcode
Boston, United States

Common questions

What is 'high-risk melanoma'?

High-risk melanoma means the cancer has a higher chance of coming back after being removed by surgery, often due to its stage or characteristics.

What is Pembrolizumab?

Pembrolizumab is a type of medicine called an immunotherapy that helps your immune system find and fight off cancer cells.

What is Intismeran Autogene?

Intismeran Autogene is a new, personalised treatment designed to teach your body's immune system to recognise and attack your specific melanoma cancer cells.

Will I know which treatment I am receiving?

No, you won't know if you're receiving the new personalised treatment plus Pembrolizumab or just Pembrolizumab alone. This is decided by chance to ensure the study results are fair.

Can I stop participating in the study at any time?

Yes, you have the right to leave the study at any point without it affecting your usual medical care.