NCT07421739

Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: Aura Biosciences · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To assess subject-centric real-world evidence of QoL outcomes in subjects enrolled in the global Phase 3 AU-011-301 clinical trial.

Detailed description

The AU-011-404 study complements the AU-011-301 clinical trial, and aims to identify the broader impact of bel-sar treatment on subjects' daily lives and overall well-being through the collection of PROs. This noninterventional PRO study will provide valuable insights of treatment impact by capturing real-world perspective on aspects including symptom management, functional status, and overall health-related quality of life (QoL). The sites will direct interested participants to the study via a unique URL. Upon accessing the URL, participants will be asked to complete screening questions to confirm their eligibility and review/sign an informed consent document (ICD). Eligible participants will then be asked to complete custom survey questions and the EORTC QLQ-OPT30 questionnaire for up to 24 months.

Conditions

• Choroidal Melanoma
• Indeterminate Lesions
• Uveal Melanoma
• Ocular Melanoma

Interventions

Type	Name	Description
OTHER	Non-interventional, digital, patient-reported, real-world study	Surveys will be collected at the following key timepoints: Scheduled visits: Visit 2\_Cycle 1\_Day 1 Visit 8 (week 4, Day 29) Visit 19 (24-hr f/y +/- 4hrs last tx) Visit 20 (week 12, day 84) Visit 22 (week 20, day 84) Visit 25 (week 52, day 364) Visit 26 (week 65, day 455) Visit 27 (week 78, day 546) Visit 28 (week 91, day 637) Visit 29 (week 104, day 728) End of Trial or Early Termination

Timeline

• Start date: 2025-11-12
• Primary completion: 2028-08-15
• Completion: 2028-08-15
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: Australia