Choroidal MelanomaNCT07421739

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

An observational study of Choroidal Melanoma and Indeterminate Lesions, run by Aura Biosciences at 1 site in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

To assess subject-centric evidence of QoL outcomes in a subset of subjects enrolled in the global Phase 3 AU-011-301 clinical trial. Read more about this study

Who is it for?: Any age
Conditions the study is for: Choroidal Melanoma, Indeterminate Lesions, Uveal Melanoma
What is being tested?: Non-interventional, digital, patient-reported, study
How many people: 15 participants
Where: 1 siteAustralia
Study dates: 12 Nov 2025to 15 Aug 2028
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Participating in Aura's Phase 3 CoMpass trial.

Who may be able to join

Have enrolled in the Aura-sponsored clinical trial AU-011-301.

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Australia1 site

Eye Research Australia
East Melbourne, Victoria, 3002

Other trials in Australia

About this study

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

Read the 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 subject perspective on aspects including symptom management, functional status, and overall health-related quality of life (HRQOL).

The sites will direct interested participants to the study via a unique URL. Upon accessing the URL, participants will be asked to review/sign an informed consent document (ICD). Alternatively, subjects may review and sign a paper version of the informed consent document. Eligible participants will then be asked to answer custom survey questions followed by the EORTC QLQ-C30 and the EORTC QLQ-OPT30 questionnaires at required visits for up to 24 months.

Conditions: Choroidal Melanoma, Indeterminate Lesions, Uveal Melanoma, Ocular Melanoma
Being tested: Non-interventional, digital, patient-reported, study
Keywords: Uveal Melanoma, Eye Cancer, Ocular Melanoma, Choroidal Melanoma
Medical subject headings: Uveal Melanoma, Eye Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Non-interventional, digital, patient-reported, studyOther
Surveys will be collected at the following CoMpass trial visits.
Scheduled visits:
Visit 2 Visit 8 Visit 19 Visit 20 Visit 22 Visit 25 Visit 26 Visit 27 Visit 28 Visit 29 And any SOC (Standard of care) Visit

Study groups in NCT07421739
Study group	Role	What they receive
No Intervention		Observational Receives: Other: Non-interventional, digital, patient-reported, study

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Group Core Questionnaire (EORTC )QLQ-C30 scores at weeks 65 and 104.
Change from baseline in EORTC QLQ-C30 scores at weeks 65 and 104 assesses the impact of disease and treatment on the quality of life of patients with cancer. For the minimum and maximum values: All of the scales and single-item measures range in score from 0 to 100.
For whether higher scores mean a better or worse outcome: A high-scale score represents a higher response level. Hence high scores for a functional scale represent a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems (A positive change from baseline in functional scales and global health status indicates improvement, while a negative change in symptom scales indicates symptom improvement).
Measured: 24 months

Secondary outcomes (1)

Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Group Questionnaire, Ophthalmic Module (EORTC) QLQ-OPT30 scores at weeks 65 and 104.
Change from baseline in EORTC QLQ-OPT30 scores at weeks 65 and 104 assesses the impact of disease and treatment on the quality of life of patients with ophthalmic cancer specifically.
For whether higher scores mean a better or worse outcome: A high-scale score represents a higher response level. Hence high scores for a functional scale represent a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems (A positive change from baseline in functional scales and global health status indicates improvement, while a negative change in symptom scales indicates symptom improvement).
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Nov 202515 Aug 2028

First posted19 Feb 2026
Study start12 Nov 2025
Primary completion15 Aug 2028 (estimated)
Study completion15 Aug 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Choroidal MelanomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 15 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07421739
Sponsor's protocol ID: AU-011-404
Status last verified: Oct 2026
First submitted: 12 Jan 2026
Last updated: 22 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma
Choroidal Melanoma, Indeterminate Lesions
Enrolling by invitationObservational study
A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma
Choroidal Melanoma, Indeterminate Lesions
Active, not recruitingObservational study
A Registry of Subjects With Primary Indeterminate Lesions or Choroidal Melanoma
Choroidal Melanoma, Indeterminate Lesions of Eye
Active, not recruitingPhase 2
Transarterial Chemoembolization for the Treatment of Uveal Melanoma With Liver Metastases
Metastatic Malignant Neoplasm in the Liver, Metastatic Uveal Melanoma

All Choroidal Melanoma trials