Choroidal MelanomaPhase 3CoMpassNCT06007690
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
A Phase 3 study testing Bel-sar, Suprachoroidal Microinjector and Infrared Laser in people with Choroidal Melanoma and Indeterminate Lesions, run by Aura Biosciences at 53 sites in 14 countries.
Trial summary
The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choroidal Melanoma, Indeterminate Lesions, Uveal Melanoma
- What is being tested?
- Bel-sar, Suprachoroidal Microinjector and Infrared Laser
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 53 sitesin 14 countries
- Study dates
- 6 Dec 2023to 15 Aug 2028
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)
- Have no evidence of metastatic disease confirmed by imaging
- Be treatment naive for IL/CM (subjects who received PDT may be eligible)
Who cannot join
- Have known contraindications or sensitivities to the study drug or laser
- Active ocular infection or disease
Trial locations and contacts
53 sites in 14 countries.
53 sites in 14 countries
United States25 sites
W.K. Kellogg Eye Center - University of Michigan
Ann Arbor, Michigan, 48105
Emory Eye Center
Atlanta, Georgia, 30322
Austin Retina Associates
Austin, Texas, 78705
Vitreoretinal Associates of Washington
Bellevue, Washington, 98004
Tufts Medical Center New England Eye Center
Boston, Massachusetts, 02111
Massachusetts Eye and Ear
Boston, Massachusetts, 02114
University of Illinois at Chicago
Chicago, Illinois, 60612
Cole Eye Institute
Cleveland, Ohio, 44195
Texas Retina Associates
Dallas, Texas, 75231
Retina Consultants of Carolina
Greenville, South Carolina, 29605
Eye Cancer Associates of Texas
Houston, Texas, 77057
Doris Stein Eye Research Center
Los Angeles, California, 90095
University of Wisconsin Madison
Madison, Wisconsin, 53705
Tennessee Retina, PC
Nashville, Tennessee, 37203
Columbia University Irving Medical Center
New York, New York, 10032
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73104
Retina Consultants of Oklahoma
Oklahoma City, Oklahoma, 73112
Stanford University School of Medicine
Palo Alto, California, 94303
Shields & Shields PC-Wills Eye Institute
Philadelphia, Pennsylvania, 19107
Mayo Clinic
Rochester, Minnesota, 55905
Associated Retinal Consultants (ARC) P.C.
Royal Oak, Michigan, 48073
Retinal Consultants Medical Group, Inc.
Sacramento, California, 95825
Retina Associates of Utah
Salt Lake City, Utah, 84107
University of Washington Medical Center
Seattle, Washington, 98104
Retina Center of Texas
Southlake, Texas, 76092
Germany4 sites
Charité - Universitätsmedizin Berlin KöR
Berlin, 12203
Universitätsmedizin Essen
Essen, 45147
Uniklinikum Hamburg Eppendorf
Hamburg, 20246
Klinikum der LMU Muenchen
München, 80336
Italy4 sites
AOUC Azienda Ospedaliero-Universitaria Careggi
Florence, 50134
Istituto Nazionale dei Tumori, Fondazione IRCCS
Milan, 20133
Ospedale Fatebenefratelli e Oftalmico, ASST Fatebenefratelli Sacco
Milan, 20157
Universita'Cattolica Del Sacro Cuore - UNICATT
Roma, 00168
Spain4 sites
Hospital Universitario de Bellvitge
Barcelona, 08907
Hospital Provincial de Conxo
Santiago de Compostela, 15706
Hospital Virgen Macarena
Seville, 41009
Hospital Universitario Y Politécnico La Fe
Valencia, 46026
Czechia3 sites
Fakultni nemocnice Plzen
Pilsen, Plzenský Kraj, 32300
Fakultni Thomayerova nemocnice
Prague, Krč, 14059
Ustredni vojenska nemocnice Vojenska fakultni nemocnice Praha
Prague, 16902
Austria2 sites
Medical University Graz
Graz, 8036
Medizinische Universität Wien, Department of Ophthalmology and Optometry
Vienna, 1090
France2 sites
Hospices Civils de Lyon - Hôpital de La Croix Rousse - Hospital
Lyon, Rhone, 69004
Centre Hospitalier Universitaire de Nice
Nice, Cedex 1, 06001
Netherlands2 sites
Leids Universitair Medisch Centrum (LUMC)
Leiden, 2333 ZE
Erasmus MC
Rotterdam, 3015AA
United Kingdom2 sites
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD
Nhs Foundation Trust - Royal Hallamshire Hospital
Sheffield, S10 2JF
Israel1 site
The Chaim Sheba Medical Center
Tel-Hashomer, Central District, 5262100
About this study
The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).
Read the detailed description
This is a randomized, sham-controlled, subject-, assessor-, and Sponsor- masked trial to establish the safety and efficacy of bel-sar treatment via suprachoroidal (SC) administration in subjects with primary IL/CM. Bel-sar treatment incorporates administration of bel-sar drug product using a suprachoroidal space (SCS) microinjector and activation of bel-sar by a laser photoactivation device.
- Being tested
- Bel-sar, Suprachoroidal Microinjector, Infrared Laser, Sham Infrared Laser, Sham Microinjector
- 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.
Bel-sarDrug
Also called AU-011
Bel-sar via suprachoroidal administration followed by laser application.
Suprachoroidal MicroinjectorDevice
Also called SCS Microinjector
Suprachoroidal injection device
Infrared LaserDevice
Laser application
Sham Infrared LaserDevice
Sham laser application
Sham MicroinjectorDevice
Sham injection device
| Study group | Role | What they receive |
|---|---|---|
| High dose bel-sar treatment arm & laser application | Experimental | High dose of bel-sar + laser application Receives: Drug: Bel-sar; Device: Suprachoroidal Microinjector; Device: Infrared Laser |
| Low dose bel-sar treatment arm & laser application | Experimental | Low dose of bel-sar + laser application Receives: Drug: Bel-sar; Device: Suprachoroidal Microinjector; Device: Infrared Laser |
| Sham control arm & sham laser | Sham comparator | Sham injection + sham laser Receives: Device: Sham Infrared Laser; Device: Sham Microinjector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach tumor progression
Tumor Progression
Measured: 65 weeks
Secondary outcomes (1)
Time to composite endpoint
Tumor progression or visual acuity failure
Measured: 65 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start6 Dec 2023
- Primary completion15 Nov 2027 (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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aura Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Aura Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007690
- Sponsor's protocol ID
- AU-011-301
- Acronym
- CoMpass
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06007690
- Acronym / sponsor ID
- CoMpass / AU-011-301
- Keywords
- Uveal Melanoma, Eye Cancer, Ocular Melanoma, Choroidal Melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Aura BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Aug 2028 (estimated)
- First posted
- 23 Aug 2023 (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.
The primary objective is to determine the safety and efficacy of belzupacap sarotalocan (bel-sar) compared to sham control in patients with primary indeterminate lesions (IL) or small choroidal melanoma (CM).
Detailed description
This is a randomized, sham-controlled, subject-, assessor-, and Sponsor- masked trial to establish the safety and efficacy of bel-sar treatment via suprachoroidal (SC) administration in subjects with primary IL/CM. Bel-sar treatment incorporates administration of bel-sar drug product using a suprachoroidal space (SCS) microinjector and activation of bel-sar by a laser photoactivation device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose bel-sar treatment arm & laser application | Experimental | Drug: Bel-sar, Device: Suprachoroidal Microinjector, Device: Infrared LaserHigh dose of bel-sar + laser application |
| Low dose bel-sar treatment arm & laser application | Experimental | Drug: Bel-sar, Device: Suprachoroidal Microinjector, Device: Infrared LaserLow dose of bel-sar + laser application |
| Sham control arm & sham laser | Sham comparator | Device: Sham Infrared Laser, Device: Sham MicroinjectorSham injection + sham laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of primary indeterminate lesion or small choroidal melanoma (IL/CM)
- Have no evidence of metastatic disease confirmed by imaging
- Be treatment naive for IL/CM (subjects who received PDT may be eligible)
Key exclusion criteria (2 listed)
- Have known contraindications or sensitivities to the study drug or laser
- Active ocular infection or disease
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 |
|---|---|---|
| Bel-sarAlso: AU-011Bel-sar via suprachoroidal administration followed by laser application. | Drug | High dose bel-sar treatment arm & laser application, Low dose bel-sar treatment arm & laser application |
| Suprachoroidal MicroinjectorAlso: SCS MicroinjectorSuprachoroidal injection device | Device | High dose bel-sar treatment arm & laser application, Low dose bel-sar treatment arm & laser application |
| Infrared LaserLaser application | Device | High dose bel-sar treatment arm & laser application, Low dose bel-sar treatment arm & laser application |
| Sham Infrared LaserSham laser application | Device | Sham control arm & sham laser |
| Sham MicroinjectorSham injection device | Device | Sham control arm & sham laser |
Primary outcome
Time to reach tumor progression
Time frame: 65 weeks
Tumor Progression
1 secondary outcome
Time to composite endpoint
Time frame: 65 weeks
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 13 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.
Medical Monitor study director
Aura Biosciences
53 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bel-sar, Suprachoroidal Microinjector and Infrared Laser in people with Choroidal Melanoma and Indeterminate Lesions, run by Aura Biosciences at 53 sites in 14 countries.
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 3 inclusion and 2 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 13 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 53 sites in United States, Germany, Italy, Spain, Czechia and 9 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to reach tumor progression (time frame: 65 weeks). 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 13 Oct 2026.