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

United States100 participantsStarted 2023-12-06

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * Have known contraindications or sensitivities to the study drug or laser * Active ocular infection or disease

What they're measuring

Time to reach tumor progression

Timeframe: 65 weeks

Trial details

NCT IDNCT06007690

SponsorAura Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-11-15

Contact for this trial

Medical Monitor

617-500-8864 clinical@aurabiosciences.com

View on ClinicalTrials.gov More Choroidal Melanoma trials