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

NCT07421739 | Recruiting

• 1 other identifier: AU-011-404
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Uveal Melanoma; Eye Cancer; Ocular Melanoma; Choroidal Melanoma

Outcome Measures

Primary Outcomes (1)

• Change from baseline in EORTC QLQ-C30 scores at month 15 and 24.

  Change from baseline in EORTC QLQ-C30 scores at month 15 and 24 assesses the impact of disease and treatment on cancer patients' quality of life.

  24 months

Secondary Outcomes (1)

• Change from baseline in EORTC QLQ-OPT30 scores at months 15 and 24.

  24 months

Study Arms (1)

No Intervention

Observational

Other: Non-interventional, digital, patient-reported, real-world study

Interventions

Non-interventional, digital, patient-reported, real-world study OTHER

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

No Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participating in Aura's Phase 3 CoMpass trial.

You may qualify if:

• Have enrolled in the Aura-sponsored clinical trial AU-011-301.
• Access to a connected device (i.e., smartphone, laptop, or tablet)

You may not qualify if:

• None

Sponsors & Collaborators

• Aura Biosciences: lead
• Vitaccess Ltd: collaborator

Study Sites (1)

Eye Research Australia

East Melbourne, Victoria, 3002, Australia

RECRUITING

Related Links

• Aura Biosciences

MeSH Terms

Conditions

Uveal Melanoma; Eye Neoplasms

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Study Officials

• Study Director

  Aura Biosciences

  STUDY DIRECTOR

Central Study Contacts

Medical Monitor

CONTACT

617-500-8864; clinical@aurabiosciences.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: February 19, 2026
• Study Start: November 12, 2025
• Primary Completion (Estimated): August 15, 2028
• Study Completion (Estimated): August 15, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)