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A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects with Primary Indeterminate Lesions or Small Choroidal Melanoma


Primary Investigator
Demirci, Hakan
Status
OPEN TO ACCRUAL
Phase
III
NCT Number
NCT06007690
UM Number
2023.081
Age Group
Adults
Management Group
CTSU - Michigan
Oncology Group
Cutaneous Oncology
ID (Protocol)
46139
Secondary Protocol No
HUM00233729
Scope
Unspecified
Sponsor Type
Industry

Disease Site
Eye and Orbit

Summary
The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).

Eligibility: