Clinical Trial

A Randomised Phase II Study of Roginolisib in Patients With Advanced/Metastatic Uveal Melanoma

Study acronym: OCULE-01
Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to learn how roginolisib works in comparison to standard treatment in adult patients with uveal/ocular melanoma. The main questions it aims to answer are: Does roginolisib extend overall survival compared to standard treatment? How does dosing of roginolisib impact quality of life compared to standard treatment?
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2024-11-29; most recent amendment 2026-01-15.
Status change: Recruiting → Active, Not Recruiting 2026-01-15
Status change: Not Yet Recruiting → Recruiting 2025-02-13
Trial Details
NCT Number NCT06717126
Lead Sponsor iOnctura
Conditions Uveal Melanoma, Ocular Melanoma
Enrollment 85 participants
Start Date 2025-02-27
Primary Completion 2027-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-16