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

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Trial ID: NCT06007690

Age - 18 Years- Condition - Skin (Cutaneous) Cancer, Skin - Melanoma Gender - ALL Accepting Healthy Volunteers - yes

Purpose

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).

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

Stanford Investigator(s)

Prithvi Mruthyunjaya, MD, MHS
Prithvi Mruthyunjaya, MD, MHS

Alan Adler Professor of Ophthalmology and Professor, by courtesy, of Radiation Oncology

Eligibility

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

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Intervention(s):

device: Suprachoroidal Microinjector

device: Infrared Laser

device: Sham Infrared Laser

device: Sham Microinjector

drug: Bel-sar

Recruiting

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Naz Jehangir

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