IMC-F106C vs Nivolumab for Melanoma
(PRISM-MEL-301 Trial)
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you have an active autoimmune disease requiring immunosuppressive treatment, you may not be eligible to participate.
What data supports the effectiveness of the drug IMC-F106C for melanoma?
Tebentafusp, a similar drug to IMC-F106C, has shown a survival benefit in patients with metastatic uveal melanoma, indicating potential effectiveness in targeting melanoma cells. Additionally, nivolumab, another component of the treatment, has been effective in treating skin melanoma, suggesting that combining these therapies could improve outcomes for melanoma patients.12345
What is the safety profile of Nivolumab and related treatments for melanoma?
Nivolumab, also known as Opdivo, is generally considered safe for treating melanoma, but it can cause side effects like fatigue, diarrhea, and skin rash. It may also lead to immune-related reactions, which can be serious. Long-term safety data show that while it has high antitumor activity, it can cause immune-related adverse events that need careful management.678910
How does the drug IMC-F106C differ from other melanoma treatments?
IMC-F106C is a novel treatment that targets PRAME (a cancer-associated protein) and CD3 (a protein on T-cells), potentially offering a unique mechanism compared to existing melanoma treatments like nivolumab and relatlimab, which target PD-1 and LAG-3 proteins to boost the immune response against cancer.211121314
What is the purpose of this trial?
This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A\*02:01-positive participants with previously untreated advanced melanoma.
Eligibility Criteria
This trial is for adults with advanced melanoma who haven't been treated before. They must have a specific genetic marker (HLA-A*02:01), be able to use effective birth control, and have a certain level of physical fitness (ECOG score 0 or 1). People can't join if they have serious lung or heart problems, other cancers, untreated brain metastases, allergies to the drugs being tested, active autoimmune diseases needing treatment, prior cancer therapy for their melanoma, or severe reactions to similar drugs.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive brenetafusp (IMC-F106C) plus nivolumab or standard nivolumab regimens
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- IMC-F106C
- Nivolumab
- Relatlimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Immunocore Ltd
Lead Sponsor