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Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects
Sponsor: Aura Biosciences
Summary
To assess subject-centric real-world evidence of QoL outcomes in subjects enrolled in the global Phase 3 AU-011-301 clinical trial.
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
15
Start Date
2025-11-12
Completion Date
2028-08-15
Last Updated
2026-02-19
Healthy Volunteers
No
Interventions
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
Locations (1)
Eye Research Australia
East Melbourne, Victoria, Australia