What side effects are associated with this type of intervention?

Common treatments for choroidal melanoma include radiation therapy (such as brachytherapy and proton beam therapy) and laser treatments. These treatments can lead to side effects such as radiation retinopathy, optic neuropathy, cataracts, and dry eye. Radiation retinopathy can cause vision loss due to damage to the retinal blood vessels, while optic neuropathy can result in optic nerve damage. Cataracts may develop due to radiation exposure, leading to clouding of the lens and impaired vision. Dry eye symptoms can occur due to damage to the tear-producing glands. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Historically, the FDA has approved treatments for choroidal melanoma that include radiotherapy options such as plaque brachytherapy and proton beam therapy. Additionally, surgical options like enucleation have been standard. There are no specific FDA-approved systemic drugs for choroidal melanoma similar to Belzupacap Sarotalocan mentioned in the provided context. However, ongoing research and clinical trials continue to explore novel therapeutic approaches, including targeted therapies and immunotherapies.

What other types of research exist?

Promising novel alternatives to Belzupacap Sarotalocan for Choroidal Melanoma patients include: 1) AU-011 (belzupacap sarotalocan) via suprachoroidal administration, which is currently under investigation for its safety and efficacy. 2) Immunotherapy agents such as pembrolizumab and nivolumab, which have shown potential in treating various melanomas. 3) Targeted therapies like selumetinib, a MEK inhibitor, which has been explored for uveal melanoma. 4) Radiotherapy options like proton beam therapy, which offers precise targeting of ocular tumors with minimal damage to surrounding tissues.

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Virus Therapy

AU-011 for Eye Melanoma

Phase 2

Waitlist Available

Research Sponsored by Aura Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have no evidence of metastatic disease confirmed by imaging

Be treatment naïve for IL/CM

Must not have

Active ocular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called belzupacap sarotalocan for patients with specific eye conditions. The drug is injected into the eye and activated by a laser. The goal is to see if it is safe and effective.

Who is the study for?

This trial is for individuals with a clinical diagnosis of primary indeterminate lesions or small choroidal melanoma, who haven't had any previous treatments for these conditions and have no signs of the cancer spreading to other parts of the body. People can't join if they are allergic or sensitive to the study drug or laser treatment, or if they have an active eye disease.

What is being tested?

The trial is testing belzupacap sarotalocan (AU-011) delivered into the eye using a special microinjector followed by PDT laser treatment. The goal is to see how safe and effective this approach is in treating small tumors in the eye related to melanoma.

What are the potential side effects?

Potential side effects may include discomfort at injection site, inflammation inside the eye, changes in vision, and sensitivity to light due to AU-011 and PDT laser therapy. Specific side effect profiles will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My scans show no signs of cancer spread.

Select...

I have not received any treatments for my condition.

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I have been diagnosed with a small eye melanoma or an uncertain eye lesion.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have an active eye condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment related AEs and treatment related serious adverse events (SAEs).

Secondary study objectives

Time to reach tumor progression

Within-subject difference of historical tumor thickness growth rate and post-treatment growth rate over 52 weeks.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Cohort 6 AU-011 & LaserExperimental Treatment3 Interventions

High dose of AU-011/laser applications administered weekly for 3 treatments and up to 3 cycles of treatment.

Group II: Cohort 5 AU-011 & LaserExperimental Treatment3 Interventions

AU-011/laser applications from Cohorts 1 to 3 administered weekly for 3 treatments. Up to 2 cycles of this regimen may be administered and subjects have the option of receiving a third cycle of treatment.

Group III: Cohort 4 AU-011 & LaserExperimental Treatment3 Interventions

Highest tolerated dose of AU-011/laser applications from Cohorts 1 to 3 administered weekly for 2 treatments

Group IV: Cohort 3 AU-011 & LaserExperimental Treatment3 Interventions

Medium dose of AU-011 + 2 laser applications

Group V: Cohort 2 AU-011 & LaserExperimental Treatment3 Interventions

Medium dose of AU-011 + 1 laser application

Group VI: Cohort 1 AU-011 & LaserExperimental Treatment3 Interventions

Low dose of AU-011 + 1 laser application

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AU-011

2020

Completed Phase 2

~30

PDT Laser

2020

Completed Phase 2

~30

Suprachoroidal Microinjector

2020

Completed Phase 2

~30

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Choroidal Melanoma include charged-particle radiation therapy, plaque brachytherapy, and photodynamic therapy. Charged-particle radiation therapy uses protons or other charged particles to deliver precise radiation doses to the tumor, minimizing damage to surrounding tissues. Plaque brachytherapy involves placing a radioactive plaque near the tumor to deliver localized radiation. Photodynamic therapy uses a photosensitizing agent activated by light to destroy cancer cells. These treatments are crucial for Choroidal Melanoma patients as they offer targeted approaches to control tumor growth while preserving as much vision as possible.

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