Study of Darovasertib for Patients with Localized Uveal Melanoma

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What is this study about?

This clinical trial is focused on studying a type of eye cancer called Uveal Melanoma, which occurs in the middle layer of the eye wall. The treatment being tested is an investigational drug known as Darovasertib, also referred to by its code name IDE196 (LXS196). The purpose of the study is to evaluate how safe and tolerable this drug is when used before and after surgery or other treatments, and to see how well it works in treating primary uveal melanomas.

Participants in the study will receive Darovasertib in the form of a tablet taken orally. The study will explore the effects of the drug in two different scenarios: before surgery to potentially shrink the tumor and after surgery to prevent the cancer from returning. The study will monitor the occurrence of any side effects and how the drug affects the need for different types of treatment, such as whether surgery can be avoided or if radiation therapy is more effective after taking the drug.

The trial will also assess changes in the size of the tumor and the impact on vision over time. Participants will undergo regular eye examinations to check for any signs of the cancer returning or progressing. The study aims to provide valuable information on the potential benefits of using Darovasertib in treating Uveal Melanoma and improving patient outcomes.

1 joining the study

Upon joining the study, you will be required to provide written, informed consent. This confirms your understanding and agreement to participate in the clinical trial.

You will undergo an initial assessment to confirm your eligibility. This includes verifying your diagnosis of localized uveal melanoma and ensuring you meet other health criteria.

2 initial treatment phase

You will begin the treatment with the investigational drug IDE196 (Darovasertib). This medication is taken orally in the form of a tablet.

The dosage and frequency of the medication will be determined by the study team based on your specific needs and health status.

3 monitoring and follow-up

Throughout the trial, regular monitoring will be conducted to assess your response to the treatment. This includes medical examinations and laboratory tests.

You will be required to attend scheduled follow-up visits to evaluate the safety and effectiveness of the treatment.

4 completion of treatment

After completing the treatment phase, you will undergo a final assessment to determine the overall impact of the medication on your condition.

The study team will provide guidance on any further steps or treatments that may be necessary based on your response to the trial.

Who Can Join the Study?

Must be at least 18 years old.
Must be able to provide written, informed consent and follow the study requirements.
Must have a primary diagnosis of localized uveal melanoma (a type of eye cancer) with no signs of it spreading beyond the eye.
Must plan to undergo either enucleation (removal of the eye) or plaque brachytherapy (a type of radiation treatment).
For those recommended for enucleation, the tumor must be up to 22 mm in largest diameter and up to 15 mm in thickness.
For those recommended for plaque brachytherapy, the tumor must be at least 6 mm in diameter and at least 3 mm in thickness, without involving critical areas like the optic nerve.
Must be able to swallow medication given by mouth.
If genetic testing has not been done, must be willing to provide a cheek swab and a small tissue sample from the tumor.
Must be able to stop taking certain medications like aspirin before surgery.
Must have an ECOG performance status of 0 or 1, which means being fully active or having some symptoms but still able to do light work.
Must not have other eye diseases that could affect vision tests during the study.
Must have adequate organ function, including:
- Enough white blood cells and platelets (types of blood cells).
- Hemoglobin level of at least 9.0 g/dL (a measure of red blood cells).
- Normal liver and kidney function tests.
Female participants who can have children must not be pregnant or breastfeeding and must have a negative pregnancy test before starting the study.
Females of childbearing potential must agree to use effective birth control during the study and for 30 days after the last dose of the study drug.
Males who are sexually active with females of childbearing potential must agree to use effective birth control during the study and for 90 days after the last dose of the study drug.

Who Cannot Join the Study?

Patients with any other type of cancer besides Uveal Melanoma cannot participate.
Patients who have had a different cancer in the past 5 years are not eligible.
Patients with serious heart problems are excluded.
Patients with uncontrolled high blood pressure cannot join the study.
Patients with active infections that need treatment are not allowed to participate.
Patients who are pregnant or breastfeeding cannot take part in the trial.
Patients who have participated in another clinical trial in the last 30 days are not eligible.
Patients with known allergies to the study medication cannot join.
Patients with severe liver or kidney disease are excluded.
Patients who are unable to follow the study procedures are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Academisch Ziekenhuis Leiden	Leiden	The Netherlands
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Urfixfcuddiypbotsrjru Eagej Aim	Essen	Germany
Ihoqoppw Cipai	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	30.11.2023
Germany	Not recruiting	30.11.2023
Italy	Not recruiting	30.11.2023
The Netherlands	Not recruiting	30.11.2023

Trial locations

Investigated drugs:

Darovasertib is a medication being studied for its potential to treat a type of eye cancer called ocular melanoma. In this clinical trial, it is being tested to see how safe and tolerable it is for patients when used before and after surgery. The goal is to understand how well it works in shrinking or controlling the cancer in the eye. Patients will receive this medication to see if it can help manage their cancer effectively.

Investigated diseases:

Uveal melanoma

Uveal Melanoma – Uveal melanoma is a type of cancer that occurs in the eye, specifically in the uvea, which includes the iris, ciliary body, and choroid. It begins when cells in the uvea develop changes in their DNA, leading to uncontrolled growth and formation of a tumor. As the disease progresses, the tumor can grow larger and may cause symptoms such as visual disturbances or changes in the appearance of the eye. The tumor can also spread to other parts of the body, although this is not always the case. The progression of uveal melanoma can vary, with some tumors growing slowly and others more rapidly. Monitoring and regular eye examinations are important to assess the growth and changes in the tumor.

Trial ID:

2023-506683-14-00

Protocol code:

IDE196-009

NCT ID:

NCT05907954

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Darovasertib for Patients with Localized Uveal Melanoma

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