IMC-F106C Regimen Versus Nivolumab Regimens inPreviously Untreated Advanced Melanoma(PRISM-MEL-301)
Research type
Research Study
Full title
A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301)
IRAS ID
1008684
Contact name
Nicola McKelvie
Contact email
Sponsor organisation
Immunocore Limited
Research summary
Despite recent progress in advanced (unresectable or metastatic) melanoma therapy, newly diagnosed patients with advanced disease continue to have a poor prognosis, with a 5-year relative survival rate of 32%. Therefore, new and improved therapies are needed to delay progression and prolong overall survival (OS).
The main purpose of this research study is to learn if the study drug (IMC-F106C), in combination with a standard therapy (nivolumab), works better than the standard therapy (nivolumab alone or in combination with relatlimab) at making tumours stop growing (or shrink). A second purpose is to better understand the safety of IMC-F106C in combination with nivolumab and to learn whether a lower or higher dose of IMC-F106C in combination with this standard therapy works better and/or is safer. This study will also look at how well patients feel after receiving the study drug or the standard therapy. Around 680 adult patients will participate in this multi-center study.
In the UK, patients will be assigned to receive a lower dose of the study drug + nivolumab (Group A), a higher dose of the study drug + nivolumab (Group B), or nivolumab (Group C). Treatment will be administered until disease progression, unacceptable toxicity or withdrawal of consent, whichever occurs first.
IMC-F106C may have side effects that are not known yet and that cannot be predicted, including ones that are life-threatening or fatal. Patients will be required to attend clinic/hospital visits where study procedures will be performed. Patients will be monitored throughout the study; participation is voluntary and informed consent is mandatory.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
23/LO/0886
Date of REC Opinion
20 Dec 2023
REC opinion
Further Information Favourable Opinion