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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

Study acronym: CoMpass
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites reduced: 66 → 53 locations
    • Eligibility criteria expanded, about 5 words
  2. Enrollment closed, study ongoing
    • Trial sites reduced: 71 → 66 locations
    • Enrollment target: estimated 100 to confirmed 108
    v16
  3. Study sites: 66 to 71v15
  4. Primary completion date: Mar 1, 2026 to Nov 15, 2027
    • Study sites: 63 to 66
    • Study completion date: Mar 1, 2027 to Aug 15, 2028
    v14
  5. Study sites: 58 to 63v13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 54 to 58v12
  2. Study sites: 51 to 54v11
  3. Study sites: 46 to 51v10
  4. Study sites: 49 to 46v9
  5. Study sites: 45 to 49
    • Interventions: Belzupacap Sarotalocan (Drug), Infrared Laser (Device), Sham Infrared Laser (Device), Sham Microinjector (Device), Sham Treatment (Drug)… to Bel-sar (Drug), Infrared Laser (Device), Sham Infrared Laser (Device), Sham Microinjector (Device), Suprachoroidal Microinjector (Device)
    • Secondary endpoints: details revised at 1 of 1 entry
    v8
  6. Study sites: 38 to 45v7
  7. Study sites: 32 to 38v6
  8. Study sites: 31 to 32v5
  9. Study sites: 33 to 31
    • Start date changed from estimate of Sep 30, 2023 to Dec 6, 2023
    v4
  10. Site details revised at 6 of 33 sitesv3
  11. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Feb 1, 2027 to Mar 1, 2026
    • Study completion date: Feb 1, 2028 to Mar 1, 2027
    • Site details revised at 33 of 33 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Aura Biosciences
6 trials monitored
See 1 trial at risk
Melanoma
1,092 trials monitored
See 60 trials at risk
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).
Trial Details
NCT Number NCT06007690
Lead Sponsor Aura Biosciences
Conditions
(from sponsor)		 Choroidal Melanoma, Indeterminate Lesions, Uveal Melanoma, Ocular Melanoma
Related terms Eye Neoplasms, Uveal Melanoma
Enrollment 108 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov