A Randomised Phase II Study of Roginolisib in Patients With Advanced/Metastatic Uveal Melanoma
NCT06717126 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85
Last updated 2026-01-16
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?
Conditions
- Uveal Melanoma
- Ocular Melanoma
Interventions
- DRUG
-
roginolisib
rognolisib
- DRUG
-
Investigator choice of standard therapy
Investigator will choose the most appropriate treatment standardly given to patients
Sponsors & Collaborators
-
iOnctura
lead INDUSTRY
Principal Investigators
-
Michael Lahn, MD · iOnctura
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-27
- Primary Completion
- 2027-12-31
- Completion
- 2028-12-31
Countries
- Italy
- Spain
- United Kingdom
Study Locations
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