If you or someone you love is diagnosed with advanced uveal melanoma, a rare cancer that starts in the eye, you know how few good treatment options exist. This study asked a critical question for a specific group of patients: could a new, targeted drug help them live longer than the standard treatments doctors already use? The trial focused on adults with a specific genetic marker (HLA-A*0201 positive) who had not yet received any treatment for their advanced cancer. They were randomly assigned to receive either the new drug, called IMCgp100, or one of three other treatments chosen by their doctor: dacarbazine, ipilimumab, or pembrolizumab. The main goal was to see which group had better overall survival. The study also looked at other important measures, like how long the cancer stayed under control and how many patients saw their tumors shrink. The results directly compare the survival benefit of this new approach against the current standard of care, providing clear evidence for patients and doctors facing this difficult diagnosis.
Can a new drug help people with a rare eye cancer live longer?
Plain Language Summary
What this means for you:
A new drug was tested head-to-head against existing treatments for advanced eye cancer to see which helps patients live longer. What this means for you:
A new drug was tested head-to-head against existing treatments for advanced eye cancer to see which helps patients live longer. View Original Abstract ↓
Status: COMPLETED | Phase: PHASE2
Condition(s): Uveal Melanoma
Intervention(s): IMCgp100 (BIOLOGICAL), Dacarbazine (DRUG), Ipilimumab (BIOLOGICAL), Pembrolizumab (BIOLOGICAL)
To evaluate the overall survival of HLA-A\*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator's Choice of dacarbazine, ipilimumab, or pembrolizumab.
Detailed: This Phase II study is designed to evaluate the safety and efficacy of IMCgp100 compared with Investigator's Choice (dacarbazine, ipilimumab or pembrolizumab) in HLA-A\*0201 positive adult patients with advanced UM treated in the first line setting with no prior systemic or liver-directed chemo-, radio- or immune-therapy administered in the advanced setting (prior surgical resection of liver metastases and adjuvant systemic therapy are acceptable). Comparison of the IMCgp100 efficacy results in this Phase II study will be made with the concurrently randomized arm (Investigator's Choice) with a primary endpoint of overall survival (OS) and secondary efficacy endpoints of progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), and disease control rate (DCR
Primary Outcome(s): Efficacy: Overall Survival
Enrollment: 378 (ACTUAL)
Lead Sponsor: Immunocore Ltd
Start: 2017-10-16 | Primary Completion: 2020-10-13
Results posted: 2021-09-14