Phase 2
Completed N=57
Study in Subjects With Small Primary Choroidal Melanoma
Uveal Melanoma · Ocular Melanoma · Choroidal Melanoma
Source: ClinicalTrials.gov NCT03052127 ↗
Enrolled (actual)
57
Serious AEs
7.1%
Results posted
Feb 2024
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011 — 3; 3; 3; 3 Participants
Summary
The primary objective is to assess the safety, immunogenicity and efficacy of one of three dose levels and repeat dose regimens of Light-activated AU-011 and one or two laser applications for the treatment of subjects with primary choroidal melanoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability] of Light-activated AU-011 |
3; 3; 3; 3; 3; 3 | — |
| SECONDARY Immunogenicity (Anti-AU-011 Antibody Analysis) |
2; 1; 3; 1; 0; 2 | — |
| SECONDARY Tumor Size (Thickness) Measured by Ultrasonography [Efficacy] |
1.872; 2.678; 2.389; 2.033; 2.233; 2.233 | — |
| SECONDARY Tumor Size (Diameter) Measured by Fundus Photography [Efficacy] |
7.740; 8.350; 7.700; 7.815; 8.853; 7.492 | — |
| SECONDARY Best Corrected Visual Acuity Measured by ETDRS Method [Efficacy] in Study Eye |
89.7; 81.0; 87.3; 88.3; 75.7; 87.0 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of choroidal melanoma
Exclusion Criteria
- Have known contraindications or sensitivities to the study drug
Data sourced from ClinicalTrials.gov (NCT03052127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.