Recruiting

Study of Roginolisib for Patients with Advanced Uveal Melanoma

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called Advanced Metastatic Ocular/Uveal Melanoma, which is a serious condition affecting the eye. The study will explore the effectiveness of a new treatment called Roginolisib (also known as IOA-244). This medication is being tested to see how well it works compared to other treatments chosen by doctors. The main goal is to understand how Roginolisib affects the survival of patients with this type of melanoma.

Participants in the study will receive either Roginolisib or another treatment selected by their doctor. Roginolisib is taken as a tablet, while other treatments may include medications like Dacarbazine, Opdualag (which contains Nivolumab and Relatlimab), Pembrolizumab, Yervoy (which contains Ipilimumab), or Opdivo (which contains Nivolumab). These treatments are given through an intravenous infusion, which means they are administered directly into the bloodstream through a vein.

The study will take place over several months, during which participants will be monitored regularly to assess the effects of the treatment. This includes checking for any changes in the cancer, as well as monitoring overall health and any side effects. The study aims to provide valuable information on the potential benefits of Roginolisib for patients with this challenging form of melanoma.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
A biopsy is required to confirm the diagnosis of advanced or metastatic ocular/uveal melanoma.
Step 2
Treatment allocation
Participants are randomly assigned to receive either roginolisib or a treatment chosen by the investigator.
The choice of treatment is based on the participant's previous medical treatments and current health status.
Step 3
Medication administration
If assigned to roginolisib, the medication is taken orally. The dosage and frequency are determined by the study protocol.
If assigned to the investigator's choice, medications such as dacarbazine, nivolumab, pembrolizumab, or ipilimumab are administered through intravenous infusion. The specific medication and dosage depend on the participant's treatment plan.
Step 4
Regular monitoring
Participants undergo regular monitoring to assess the effectiveness of the treatment and to check for any side effects.
This includes physical examinations, blood tests, and imaging studies to evaluate the response to treatment.
Step 5
Biopsy and imaging
A follow-up biopsy is conducted at a specified point in the study to assess the tumor's response to treatment.
Imaging studies are performed periodically to measure the size of the tumor and to detect any changes.
Step 6
Completion of treatment
The treatment phase continues until the study's end date or until the participant's condition changes.
Upon completion, a final assessment is conducted to evaluate the overall response to the treatment.
Step 7
Follow-up
After the treatment phase, participants enter a follow-up period to monitor long-term effects and overall survival.
Regular check-ups are scheduled to ensure ongoing health and to address any late-emerging side effects.

Who can join the trial?

9 criteria

Must be a male or female aged 18 years or older.
Must have a confirmed diagnosis of advanced or metastatic **ocular melanoma** (a type of eye cancer).
Must have previously received at least one **immunotherapy** treatment for advanced or metastatic ocular melanoma. If the patient has a specific genetic marker called **HLA-A*02:01**, they should have been treated with a drug called **tebentafusp**, if available and suitable. Patients who have had a treatment called **melphalan hepatic infusion** may also join.
Must have at least one **lesion** (an area of abnormal tissue) that can be biopsied (a small sample taken for testing). Biopsies are required at the start and during the study.
Must have at least one **measurable lesion** according to a standard called **RECIST v1.1**. A lesion that is biopsied cannot be used for measurement.
Must have an **ECOG performance status** of 0 to 1, which means the patient is fully active or has some symptoms but can carry out light work.
Male and female patients who can have children must agree to use highly effective birth control methods. Women must have a negative pregnancy test before starting and agree to regular testing during the study. Men must use a **barrier method** (like a condom) and avoid donating sperm during and after the study.
All other medical conditions must be well controlled and stable for at least 28 days before starting the study treatment.
Must provide signed and dated written consent before any study-specific procedures, tests, or analyses are done.

Who cannot join the trial?

7 criteria

Patients who have a different type of cancer than Advanced Metastatic Ocular/Uveal Melanoma cannot participate. This is a specific type of eye cancer that has spread to other parts of the body.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to follow the study procedures or who have conditions that might interfere with the study results cannot participate.
Patients who are pregnant or breastfeeding cannot participate, as the study may involve risks to the baby.
Patients who have participated in another clinical trial recently may not be eligible to join this study.
Patients who have certain medical conditions that could affect the study outcomes may not be eligible.
Patients who are unable to provide informed consent, which means they cannot understand and agree to the study details, cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Universitaria Senese
Responsive
Siena, Italy
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Istituto Oncologico Veneto
Responsive
Padua, Italy

Trial locations

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Investigated drugs

Roginolisib (IOA-244) is a medication being studied for its potential to treat advanced or metastatic ocular or uveal melanoma. It is being tested to see how effective it is in shrinking tumors or stopping their growth in patients with this type of cancer. Roginolisib is used as a single agent, meaning it is given alone without combining it with other cancer treatments in this study. The goal is to determine if it can improve the overall survival of patients compared to other therapies chosen by the investigators.

What is already known about the treatment

Roginolisib – Roginolisib is administered orally and is currently being studied in clinical trials for its effectiveness in treating advanced metastatic ocular/uveal melanoma. It is in the experimental phase and not yet widely recognized in medical literature as a standard treatment. The main therapeutic indication for roginolisib is its potential to treat this specific type of melanoma. At the molecular level, it works by inhibiting certain pathways that promote tumor growth, although the exact mechanism is still under investigation. Roginolisib is classified pharmacologically as a targeted cancer therapy.

Investigated diseases

Advanced Metastatic Ocular/Uveal Melanoma – This is a type of cancer that originates in the eye, specifically in the uveal tract, which includes the iris, ciliary body, and choroid. It is characterized by the uncontrolled growth of melanocytes, the cells responsible for pigment production. As the disease progresses, it can spread beyond the eye to other parts of the body, such as the liver, lungs, and bones. The spread of cancer cells to distant organs is referred to as metastasis. Symptoms may include visual disturbances, eye pain, or changes in the appearance of the eye. The progression of the disease can vary, with some cases advancing more rapidly than others.