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

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.

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.