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 Overview
=================
Brief 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).

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.

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

Conditions
-----------------
Choroidal Melanoma, Indeterminate Lesions, Uveal Melanoma, Ocular Melanoma

Intervention / Treatment
-----------------
* Drug: Belzupacap Sarotalocan
* Device: Suprachoroidal Microinjector
* Device: Infrared Laser
* Device: Sham Infrared Laser
* Device: Sham Microinjector
* Drug: Sham Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose bel-sar treatment arm & laser application<br>High dose of bel-sar + laser application | Drug: Belzupacap Sarotalocan<br>* Bel-sar via suprachoroidal administration followed by laser application.<br>* Other names: Bel-sar;Device: Suprachoroidal Microinjector<br>* Suprachoroidal injection device<br>* Other names: SCS Microinjector;Device: Infrared Laser<br>* Laser application<br>|
| Experimental: Low dose bel-sar treatment arm & laser application<br>Low dose of bel-sar + laser application | Drug: Belzupacap Sarotalocan<br>* Bel-sar via suprachoroidal administration followed by laser application.<br>* Other names: Bel-sar;Device: Suprachoroidal Microinjector<br>* Suprachoroidal injection device<br>* Other names: SCS Microinjector;Device: Infrared Laser<br>* Laser application<br>|
| Sham Comparator: Sham control arm & sham laser<br>Sham dose + sham laser | Device: Sham Infrared Laser<br>* Sham laser application<br>Device: Sham Microinjector<br>* Sham injection device<br>Drug: Sham Treatment<br>* Sham drug via sham injection followed by sham laser<br>* Other names: Placebo Vehicle;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to reach tumor progression | Tumor Progression | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to composite endpoint | Tumor progression or visual acuity failure | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uveal Melanoma, Eye Cancer, Ocular Melanoma, Choroidal Melanoma