NCT06717126

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

A Phase II, Multi-centre, Open Label, Randomised Study to Evaluate the Anti-tumour Activity of Roginolisib in Patients With Advanced/Metastatic Ocular/Uveal Melanoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: iOnctura · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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?

Detailed description

A Phase II open-label, randomised, parallel-arm study, which will assess the clinical efficacy of oral roginolisib (IOA 244 \[roginolisib hemi-fumarate\]) as monotherapy against a control of Investigator´s treatment choice in patients with advanced or metastatic uveal melanoma (UM). This study will enrol approximately 85 male and female patients aged over 18 years with advanced or metastatic UM, who have progressed following at least 1 prior immunotherapy treatment. The disease must be measurable (i.e., at least 1 measurable lesion) as per RECIST v1.1 by Computerised Tomography (CT) scan or Magnetic Resonance Imaging (MRI).

Conditions

• Uveal Melanoma
• Ocular Melanoma

Interventions

Type	Name	Description
DRUG	roginolisib	rognolisib
DRUG	Investigator choice of standard therapy	Investigator will choose the most appropriate treatment standardly given to patients

Timeline

• Start date: 2025-02-27
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2024-12-04
• Last updated: 2026-01-16

Locations

16 sites across 3 countries: Italy, Spain, United Kingdom