Active not recruitingPHASE2INTERVENTIONAL

A Randomised Phase II Study of Roginolisib in Patients With Advanced/Metastatic Uveal Melanoma

This research study is investigating a new medication called roginolisib for adults with advanced or metastatic uveal melanoma. Uveal melanoma is a rare type of cancer that starts in the eye and has spread to other parts of the body. The main aim of the study is to understand if roginolisib helps people live longer compared to standard treatments currently used for this condition. Researchers also want to find out how roginolisib affects a patient's daily life and general well-being. Approximately 85 patients who have already received at least one type of immune-boosting treatment will take part. By comparing this new drug to existing options, the study hopes to find better ways to treat this particular cancer.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

iOnctura

Enrolment target

Start

27 Feb 2025

Estimated completion

01 Dec 2028

Uveal Melanoma Ocular Melanoma

What is this study about?

This clinical trial is looking into a new treatment called roginolisib for a type of cancer known as uveal melanoma, or ocular melanoma. This is a rare cancer that starts in the eye, and the study is focused on people whose cancer has spread (metastasised) to other parts of the body or is advanced.

The main goal is to compare roginolisib with the standard treatments that doctors usually offer. Researchers want to see if roginolisib can help people live longer than current treatments. They also want to understand if roginolisib affects a person's quality of life differently from standard care. This means they will look at how the treatment impacts daily activities, comfort, and overall well-being. This information is important for finding better ways to help people with this specific type of cancer.

About 85 adult patients will be involved in this study. All participants will have previously received at least one type of immunotherapy, and their cancer will have continued to grow. By carefully studying how roginolisib works in these patients, researchers hope to gather valuable information that could lead to new treatment options in the future.

Key takeaways

This study is for adults with advanced uveal melanoma which has spread.
It’s comparing a new drug, roginolisib, with standard treatments.
The main aims are to see if roginolisib improves survival and quality of life.
You must have already had at least one immunotherapy treatment.
Participation involves regular clinic visits, scans, and blood tests.
You can withdraw from the study at any time.

Who may be eligible?

This study is for adults aged 18 or older who have been diagnosed with advanced or metastatic uveal melanoma. This means your eye cancer has spread to other parts of your body. You should have already received at least one type of immunotherapy, and your cancer should have grown since then. In some cases, if you're suitable and your cancer is a specific type (HLA-A*02:01 positive), you might have had a treatment called tebentafusp.

To be eligible, doctors need to be able to measure your cancer using scans like CT or MRI. Also, your general health should be good enough to take part, meaning you can do most of your daily activities without too much trouble, and any other health conditions you have are well managed.

You won't be able to join if you can't swallow pills, have certain severe side effects from previous treatments that haven't healed, or if your cancer has spread to your brain and is causing symptoms that haven't been treated.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced or spread uveal melanoma?
Have you already received at least one immunotherapy treatment for your cancer?
Can doctors physically measure your cancer on scans?
Are you generally well enough to do most daily activities?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will either receive the new drug roginolisib or a standard treatment chosen by your doctor. This is decided by chance, like flipping a coin. Roginolisib is taken as a pill. You will have regular visits to the clinic for medical checks, scans, and blood tests to monitor your health and how the treatment is working. You will also be asked to provide biopsies (small tissue samples) at the beginning of the study and at a specific point during the treatment.

During your time in the study, you'll be giving information about your quality of life. The doctors will monitor you closely for any side effects. The total duration of your participation will depend on how you respond to the treatment, but you will be followed up regularly. Women and men who are able to have children will need to use effective birth control throughout the study.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as access to a new treatment before it's widely available, and close medical monitoring. However, there are also potential risks; roginolisib may cause side effects, some of which could be severe or unexpected, similar to any new medication. Standard treatments also carry their own known risks and side effects. You will be fully informed of these before deciding to join. It's crucial to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (16)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

SSD Tumori Rari e Melanoma Viale Orazio Flacco
Verified postcode
Bari, Italy
IRCSS National Cancer Institute, "G.Pascale" Foundation Dip. CORP-S di Ricerca ed Assistenziale Cute, Melanoma lmmunologia Oncologica Sperimentale e Terapie Innovative
Verified postcode
Naples, Italy
IRCSS Istituto Oncologico Veneto UOS Oncologia 2 del Melanoma Ospedale Busonera
Verified postcode
Padova, Italy
IRCCS Istituto Clinico Humanitas
Verified postcode
Rozzano, Italy
A.O.U.S. Santa Maria delle Scotte
Verified postcode
Siena, Italy
Institut Catala d'Oncologia - ICO L'Hospitalet
Verified postcode
Barcelona, Spain
Hospital Universitario La Paz
Verified postcode
Madrid, Spain
Complejo Hospitalario Universitario de Santiago - CHUS
Verified postcode
Santiago de Compostela, Spain
Hospital Universitario Virgen Macarena, University of Seville
Verified postcode
Seville, Spain
Consorcio Hospital General Universitario de València - CHGUV
Verified postcode
Valencia, Spain
East and North Hertfordshire NHS Trust (Mount Vernon Cancer Centre)
Verified postcode
Northwood, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Verified postcode
Bebington, United Kingdom

Common questions

What is uveal melanoma?

Uveal melanoma is a rare type of cancer that develops in the eye. This study focuses on cases where the cancer has spread to other parts of the body.

What is roginolisib?

Roginolisib is a new drug being tested in this study. It's a pill that researchers hope will help treat advanced uveal melanoma.

Will I definitely get the new drug?

No, you will be randomly assigned to either receive roginolisib or a standard treatment chosen by your doctor. It's like a lottery.

How long will the study last for me?

The length of your participation will depend on how your body responds to the treatment. You'll have regular check-ups throughout.

Will I have to pay to be part of the study?

No, participation in clinical trials does not typically involve any cost for the treatments or procedures related to the study.