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

NCT07421739 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2026-02-19

No results posted yet for this study

Summary

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

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Vitaccess Ltd

    collaborator INDUSTRY
  • Aura Biosciences

    lead INDUSTRY

Principal Investigators

  • Study Director · Aura Biosciences

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-12
Primary Completion
2028-08-15
Completion
2028-08-15

Countries

  • Australia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07421739 on ClinicalTrials.gov