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A Phase II Randomized, Open-label, Multi-center Study of the Safety and Efficacy of IMCgp100 Compared With Investigator Choice in HLA-A*0201 Positive Patients With Previously Untreated Advanced Uveal Melanoma

Status
Active
Cancer Type
Eye Cancer
Trial Phase
Phase II
Eligibility
18 to 99, Male and Female
Study Type
Treatment
NCD ID
NCT03070392
Protocol IDs
IMCgp100-202 (primary)
NCI-2017-00590
Study Sponsor
Immunocore Ltd

Summary

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.

Objectives

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).

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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