Not yet recruitingPHASE3INTERVENTIONAL

iSCIB1+ in Combination With Ipilimumab and Nivolumab as First-Line Treatment for Advanced Unresectable Melanoma

This important study is testing a new treatment called iSCIB1+, which is a special vaccine designed to help your body's immune system fight advanced skin cancer (melanoma). It aims to find out if adding this vaccine to a common combination of immunotherapy drugs (Nivolumab and Ipilimumab) works better than the immunotherapy alone. Participants will be randomly given either the vaccine or a placebo (a dummy treatment) alongside their standard immunotherapy. The researchers will then carefully watch how their cancer responds, how long they stay well, their overall health, and their quality of life. This is a 'Phase 3' study, meaning it's a key step to see if this new approach can become a new standard treatment.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

Scancell Ltd

Enrolment target

550

Start

01 Dec 2026

Estimated completion

01 Dec 2032

Melanoma (Skin Cancer)Advanced Melanoma Metastatic Melanoma Skin Cancer

What is this study about?

This study is for people who have advanced skin cancer, also known as melanoma, which cannot be removed by surgery. Doctors are always looking for better ways to treat this type of cancer, and current immunotherapy treatments have already made a big difference. However, they don't work for everyone, and researchers believe there's still room for improvement.

This trial introduces a new treatment called iSCIB1+. This is a special kind of vaccine that's designed to teach your immune system to recognise and attack melanoma cancer cells more effectively. The idea is that if your immune system is better at finding these cells, it might work even better when combined with the immunotherapy drugs Nivolumab and Ipilimumab, which are already standard treatments.

The main goal of this study is to see if adding the iSCIB1+ vaccine to the standard immunotherapy helps people live longer without their cancer getting worse. They will also look at how long people live overall, how much the tumours shrink, and how the treatment affects their general well-being and quality of life. This research could lead to a new and more effective way to treat advanced melanoma.

Key takeaways

This study explores a new vaccine (iSCIB1+) for advanced melanoma.
It combines iSCIB1+ with standard immunotherapy drugs (Nivolumab and Ipilimumab).
The aim is to see if adding the vaccine improves how long people live without their cancer worsening.
Participants will receive either the vaccine or a placebo alongside their standard treatment.
The study monitors cancer response, survival, safety, and quality of life.
This is a Phase 3 study, a crucial step for potential new treatments.

Who may be eligible?

To join this study, you would need to have advanced melanoma that can't be removed with surgery. Doctors will also check your specific genetic make-up (called HLA type) to ensure the vaccine might work for you. You must be at least 18 years old and generally well enough to take part, with a good chance of living for at least another six months. You would also need to have at least one measurable tumour that doctors can track.

Your doctor would need to confirm that immunotherapy is a suitable treatment for your cancer. They would also need to know about any specific gene changes in your cancer (called BRAF status). Before joining, you'd have some tests to make sure your body, including your organs, is working well enough for the study treatments.

It's important that you understand what's involved and are happy to give your permission to take part. If you're a woman who could become pregnant, you'd need to use effective birth control throughout the study and for several months afterwards.

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.

Do I have advanced melanoma that cannot be removed by surgery?
Am I at least 18 years old?
Am I generally well, able to perform daily activities, and have a good life expectancy?
Have my doctors confirmed that immunotherapy is a suitable treatment for me?
Am I willing to use effective contraception if I'm a woman who could become pregnant?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to one of two groups, like flipping a coin. You'll either receive the new vaccine, iSCIB1+, or a placebo (a dummy treatment that looks the same but contains no active drug). Crucially, neither you nor your study doctor will know which one you are getting – this is called a 'blinded' study. Both groups will also receive the standard immunotherapy treatments, Nivolumab and Ipilimumab.

Taking part will involve regular visits to the hospital for your treatments, blood tests, and scans (like CT or MRI) to check how your cancer is responding. These appointments will help the study team monitor your health and any side effects. You will be followed up for your progress, safety, and other outcomes for up to four years after you first join the study.

Potential risks and benefits

Potential benefits of taking part could include receiving a new experimental treatment that might improve your outlook compared to standard care, and you'll receive very close monitoring from a dedicated medical team. However, as this is a new treatment, there's no guarantee it will work for you, and it may have side effects that aren't yet fully known. Like all medicines, Nivolumab and Ipilimumab also have known side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

University of Colorado Cancer Center
Verified postcode
Aurora, United States
Mount Vernon Cancer Centre
Verified postcode
London, United Kingdom

Common questions

What is a 'Phase 3' study?

Phase 3 means this is one of the final steps before a new treatment can become widely available. It involves many people and compares the new treatment against the best available standard treatment.

What is immunotherapy?

Immunotherapy is a type of treatment that helps your own body's immune system recognise and fight cancer cells more effectively.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks exactly like the real study drug but doesn't contain any active medicine. It helps researchers fairly compare the new treatment's effects.

Will I know if I'm getting the vaccine or the placebo?

No, neither you nor your study doctors will know which treatment you are receiving. This helps make the study results more reliable.

What does 'advanced unresectable melanoma' mean?

This means the skin cancer has spread to other parts of the body or grown too much to be completely removed by surgery.

How to find out more

Joe Thornton

joethornton@scancell.co.uk 44 (0) 1865 582 066 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.