deltatrials
Active Not Recruiting PHASE2 INTERVENTIONAL 3-arm NCT06717126

A Randomised Phase II Study of Roginolisib in Patients With Advanced/Metastatic Uveal Melanoma (OCULE-01)

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

Sponsor: iOnctura

Conditions Ocular Melanoma Uveal Melanoma
Interventions Investigator choice of standard therapy roginolisib
Updated 8 times since 2025 Last updated: Jan 15, 2026 Started: Feb 27, 2025 Primary completion: Dec 31, 2027 Completion: Dec 31, 2028
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Ocular Melanoma and Uveal Melanoma and is currently ongoing. iOnctura leads this study, which shows 8 recorded versions since 2025 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2025 – ~Feb 2025 · 31 days · monthly snapshot~Feb 2025 – ~Mar 2025 · 28 days · monthly snapshot~Mar 2025 – ~Apr 2025 · 31 days · monthly snapshot~Apr 2025 – ~May 2025 · 30 days · monthly snapshot~May 2025 – ~Jun 2025 · 31 days · monthly snapshot~Jun 2025 – ~Sep 2025 · 3 months · monthly snapshotRecruiting~Sep 2025 – ~Feb 2026 · 5 months · monthly snapshotRecruiting~Feb 2026 – present · 5 months · monthly snapshotActive Not Recruiting

Change History

8 versions recorded

  1. Feb 2026 — Present [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  2. Sep 2025 — Feb 2026 [monthly]

    Recruiting PHASE2

  3. Jun 2025 — Sep 2025 [monthly]

    Recruiting PHASE2

  4. May 2025 — Jun 2025 [monthly]

    Recruiting PHASE2

  5. Apr 2025 — May 2025 [monthly]

    Recruiting PHASE2

▶ Show 3 earlier versions

  1. Mar 2025 — Apr 2025 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  2. Feb 2025 — Mar 2025 [monthly]

    Not Yet Recruiting PHASE2

  3. Jan 2025 — Feb 2025 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • iOnctura
Data source: iOnctura

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Barcelona, Spain , Bari, Italy , Bebington, United Kingdom , Glasgow, United Kingdom , London, United Kingdom , Madrid, Spain , Napoli, Italy , Northwood, United Kingdom , Padua, Italy , Rozzano, Italy and 5 more locations