A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma

NCT07338968 | Not Yet Recruiting

• 1 other identifier: AU-011-403
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

AU-011-403 is a multicenter long-term follow-up safety and efficacy study of subjects with early CM who previously participated in the AU-011-301 Phase 3 trial. There are no required interventions or use of AU-011 (bel-sar) in this long-term follow-up study

Conditions

Choroidal Melanoma; Indeterminate Lesions

Keywords

Ocular Melanoma; Small Choroidal Melanoma

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs)/serious AEs.

  The AU-011-403 study is the long-term follow-up study of participants previously treated in AU-011-301.Long-term safety will be assessed by measuring the incidence of adverse events (AEs) and serious adverse events (SAEs) occurring during the follow-up period. AEs will be coded using the same Medical Dictionary for Regulatory Activities version used in AU-011-301 (MedDRA)

  5 years

Interventions

Observational OTHER

The intention is to collect data for an additional \~5 years (Post AU-011-301 participation)

Eligibility Criteria

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

Study Population

Subjects who have received bel-sar or sham treatment in the Aura-sponsored clinical trial AU-011-301. NCT NCT06007690

You may qualify if:

• Have received bel-sar or sham treatment in the Aura-sponsored clinical trial AU-011-301.
• Be willing and able to consent to the AU-011-403 study.

You may not qualify if:

• None

Sponsors & Collaborators

• Aura Biosciences: lead

Related Links

• Aura Biosciences

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Watchful Waiting

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; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Medical Monitor

  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: November 21, 2025
• First Posted: January 14, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 15, 2033
• Study Completion (Estimated): August 15, 2033
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share