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.
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
- Are there results?
- Not yet: the study is under way
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.
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Aura Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vitaccess Ltd
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Aura Biosciences
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects
- ClinicalTrials.gov ID
- NCT07421739
- Acronym / sponsor ID
- AU-011-404
- Keywords
- Uveal Melanoma, Eye Cancer, Ocular Melanoma, Choroidal Melanoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Aura BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Vitaccess Ltd
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 15 Aug 2028 (estimated)
- Study completion
- 15 Aug 2028 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess subject-centric evidence of QoL outcomes in a subset of subjects enrolled in the global Phase 3 AU-011-301 clinical trial.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Intervention | – | Other: Non-interventional, digital, patient-reported, studyObservational |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participating in Aura's Phase 3 CoMpass trial.
Key inclusion criteria (1 listed)
- Have enrolled in the Aura-sponsored clinical trial AU-011-301.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventional, digital, patient-reported, studySurveys 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 | Other | No Intervention |
Primary outcome
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.
Time frame: 24 months
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).
1 secondary outcome
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.
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Aura BiosciencesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Aura Biosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Choroidal Melanoma and Indeterminate Lesions, run by Aura Biosciences at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.