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NCT Number: NCT07421739

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

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

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Eye Research Australia

East Melbourne, Victoria, 3002, Australia

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

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

Primary outcomes

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

    Time frame: 24 months

    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.

Secondary outcomes

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

    Time frame: 24 months

    Change from baseline in EORTC QLQ-OPT30 scores at month 15 and 24 assesses the impact of disease and treatment on the quality of life of patients with ophthalmic cancer specifically.

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Monitor

CONTACT

[email protected]

617-500-8864

Sponsors and collaborators

Lead sponsor

Aura Biosciences

Industry

Collaborators

  • Vitaccess Ltd

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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