Ongoing Clinical Trials for Ocular Melanoma
There are currently 2 ongoing clinical trials investigating new treatments for ocular melanoma, a rare type of eye cancer. These studies are taking place across multiple European countries and are testing investigational medications aimed at slowing disease progression and improving survival for patients with advanced or early-stage forms of this condition. (Also known as: Uveal Melanoma, Choroidal Melanoma)
Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- France
- Germany
- Greece
- Ireland
- Italy
- Netherlands
- Spain
- Sweden
Study of Roginolisib for Patients with Advanced Uveal Melanoma
This trial is investigating a new treatment called Roginolisib (also known as IOA-244) for patients with advanced or metastatic uveal melanoma that has spread beyond the eye. The study compares Roginolisib to standard treatments chosen by doctors to understand which approach helps patients live longer.
Who can participate: Eligible patients must be 18 years or older with a confirmed diagnosis of advanced or metastatic ocular melanoma. Participants must have previously received at least one immunotherapy treatment. If patients have a specific genetic marker called HLA-A*02:01, they should have been treated with tebentafusp if it was available and suitable. The trial requires at least one lesion that can be biopsied at the start and during the study, and at least one measurable lesion that hasn’t been biopsied. Patients must have an ECOG performance status of 0 to 1, meaning they are fully active or have some symptoms but can still perform light activities. Both men and women of childbearing potential must agree to use highly effective birth control throughout the study, and women must have a negative pregnancy test before starting. All other medical conditions must be stable for at least 28 days before treatment begins.
Who cannot participate: Patients with cancer types other than advanced metastatic ocular or uveal melanoma are excluded. Those who are pregnant or breastfeeding cannot join due to potential risks. Patients who recently participated in another clinical trial, have certain medical conditions that could affect study outcomes, or are unable to provide informed consent are also not eligible.
What the study involves: The main goal is to evaluate how Roginolisib affects patient survival compared to standard treatments. Participants will be randomly assigned to receive either Roginolisib as an oral tablet or another treatment selected by their doctor, which may include medications like Dacarbazine, Opdualag, Pembrolizumab, Yervoy, or Opdivo. These alternative treatments are administered through intravenous infusion directly into the bloodstream. Throughout the study, participants undergo regular monitoring including physical examinations, blood tests, and imaging studies to assess treatment effectiveness and check for side effects. Follow-up biopsies are conducted at specified points to evaluate tumor response.
Investigational drug: Roginolisib works by inhibiting certain pathways that promote tumor growth. It is being tested as a single-agent therapy to determine if it can improve overall survival in patients with this challenging form of melanoma.
Study on the Effectiveness and Safety of Belzupacap Sarotalocan for Patients with Small Choroidal Melanoma or Indeterminate Lesions
This clinical trial is testing a treatment called Belzupacap Sarotalocan (AU-011) for patients with small choroidal melanoma or primary indeterminate lesions, which are abnormal growths in the eye that may or may not be cancerous. The study compares the active treatment to a placebo to evaluate its effectiveness and safety.
Who can participate: Patients eligible for this study must have a clinical diagnosis of primary indeterminate lesion or small choroidal melanoma with documented early growth, meaning there is proof that the condition has started to develop. Imaging tests must confirm that the disease has not spread to other parts of the body. Participants must be treatment naïve, meaning they have not received any previous treatment for their eye condition. However, patients who had photodynamic therapy more than 12 months ago may still be eligible after consultation with a medical expert. Both male and female patients can participate, and those from vulnerable populations are also considered.
Who cannot participate: Patients with other eye diseases that could affect study results are excluded. Those with a history of previous treatments for eye tumors, severe allergic reactions to medications, or uncontrolled medical conditions cannot participate. Pregnant or breastfeeding women are also excluded. Patients who cannot follow study procedures, attend follow-up visits, or are participating in another clinical trial simultaneously are not eligible.
What the study involves: The primary goal is to determine how well Belzupacap Sarotalocan works in slowing down or stopping the growth of lesions or melanoma, and to ensure the treatment is safe. Participants are randomly assigned to receive either the active treatment or a placebo through a sham injection, and neither the patient nor healthcare providers know which is administered. The medication is delivered as an injection into the suprachoroidal space at the back of the eye using a special device called the Clearside SCS Microinjector. Patients are monitored regularly to assess changes in tumor size and visual acuity. The primary endpoint is measured at week 65, analyzing the time it takes for the tumor to progress. The study is expected to conclude in January 2027.
Investigational drug: Belzupacap Sarotalocan is a targeted cancer therapy that uses photodynamic therapy. It works by binding to cancer cells and using light activation to destroy them while sparing healthy tissue. This approach potentially offers a new treatment option for patients with these specific eye conditions.
Summary
The two ongoing clinical trials for ocular melanoma represent different approaches to treating this rare eye cancer at various stages of disease progression. One trial focuses on advanced or metastatic disease that has spread beyond the eye, testing an oral medication called Roginolisib in patients who have already undergone immunotherapy. The second trial targets earlier-stage disease, investigating Belzupacap Sarotalocan for small tumors or uncertain lesions that have not yet been treated.
Geographically, the trials have different footprints. The Roginolisib study is being conducted in Italy and Spain, while the Belzupacap Sarotalocan trial has a much broader reach across 12 European countries including Belgium, Ireland, Denmark, Sweden, Czechia, Austria, Netherlands, Germany, Spain, France, Italy, and Greece. This wider distribution may reflect the larger patient population eligible for early-stage treatment compared to those with advanced disease.
Both studies employ different administration methods suited to their treatment targets. Roginolisib is taken orally as a tablet, making it more convenient for patients with systemic disease. In contrast, Belzupacap Sarotalocan requires specialized injection directly into the eye, which is appropriate for localized treatment of small tumors. The trials are expected to provide valuable information about treatment options for patients at different stages of this challenging condition.
