This Phase 3 clinical trial, known as PRISM-MEL-301, is investigating whether a new immunotherapy treatment called brenetafusp (IMC-F106C), given in combination with nivolumab, works better than standard nivolumab-based treatment for people with advanced melanoma that cannot be removed surgically or has spread to other parts of the body. The study is specifically for patients who are HLA-A*02:01 positive, a genetic tissue type found in around half of people. Brenetafusp is designed to help the immune system recognise and attack cancer cells by targeting a protein called PRAME, which is commonly found in melanoma cells.
This is a Phase 3 randomised study, meaning participants are placed into different treatment groups by chance. Patients will receive either brenetafusp plus nivolumab, or standard nivolumab-based treatment. Researchers are assessing whether the combination treatment can better control tumour growth, improve survival, and provide longer-lasting responses compared to current standard treatments. The trial will also compare different dose levels of brenetafusp to identify the safest and most effective dose.
The study will include around 680 participants worldwide and will closely monitor side effects, tumour response, quality of life, and overall survival. Treatment continues until the cancer progresses, side effects become unacceptable, or the participant chooses to stop treatment. UK sites are involved in this study.