Phase II trial compares IMCgp100 vs investigator choice in advanced uveal melanoma
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Key Takeaway
Review Phase II data comparing IMCgp100 to investigator choice in advanced uveal melanoma.
This Phase II study compared the safety and efficacy of IMCgp100 with investigator's choice of dacarbazine, ipilimumab, or pembrolizumab in HLA-A*0201 positive adult patients with advanced uveal melanoma. The study enrolled 378 patients who were previously untreated in the advanced setting, with no prior systemic or liver-directed chemo-, radio-, or immune-therapy allowed (prior surgical resection of liver metastases and adjuvant systemic therapy were acceptable). The study was conducted from October 16, 2017, to October 13, 2020, with results posted on September 14, 2021. The primary endpoint was overall survival, with secondary efficacy endpoints including progression-free survival, objective response rate, duration of response, and disease control rate. The abstract does not provide specific numerical results for these endpoints, safety data, or statistical comparisons between the treatment arms.
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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
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