Not yet recruitingRare disease

Study of Darovasertib and Crizotinib for Patients with HLA-A2 Negative Metastatic Uveal Melanoma

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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 eye cancer called metastatic uveal melanoma, specifically in patients who are HLA-A2 negative. The study will explore the effectiveness of a new treatment combination using two medications: IDE196 (Darovasertib) and Crizotinib. These medications are being compared to other treatments chosen by doctors. The purpose of the study is to see how well these treatments work in slowing down the progression of the disease and improving survival rates.

Participants in the study will receive either the combination of IDE196 (Darovasertib) and Crizotinib or a treatment selected by their doctor, which may include medications like Dacarbazine, Pembrolizumab, Ipilimumab, or Nivolumab. The study will last for a period of up to 12 months, during which participants will be monitored regularly to assess the effects of the treatment. The study aims to provide valuable information on the best treatment options for this specific type of cancer.

Throughout the study, participants will undergo regular check-ups and assessments to monitor their health and the progression of the cancer. The study will help determine if the new combination of IDE196 (Darovasertib) and Crizotinib is more effective than the current standard treatments. This research is important for finding better ways to treat metastatic uveal melanoma and improve outcomes for patients with this condition.

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
Joining the study
Upon joining the study, the patient will be informed about the trial's purpose and procedures. Written consent is required before any study-related activities begin.
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes verifying the diagnosis of HLA-A2 negative metastatic uveal melanoma and ensuring no prior systemic therapy in the metastatic setting.
Step 3
Randomization
The patient will be randomly assigned to receive either the combination of IDE196 (darovasertib) and crizotinib or the investigator's choice of treatment.
Step 4
Treatment administration
If assigned to the combination treatment, the patient will take IDE196 (darovasertib) and crizotinib orally. The specific dosage and frequency will be determined by the study protocol.
If assigned to the investigator's choice, the treatment may include options such as dacarbazine, pembrolizumab, ipilimumab, or nivolumab, administered via infusion or orally, depending on the selected medication.
Step 5
Monitoring and follow-up
Regular monitoring will occur to assess the patient's response to treatment and any side effects. This includes physical exams, blood tests, and imaging studies.
The patient's progress will be evaluated using criteria such as progression-free survival (PFS) and overall survival (OS).
Step 6
Completion of treatment
The treatment phase will continue until disease progression, unacceptable side effects, or the end of the study period, estimated to be in 2027.
Step 7
Post-treatment follow-up
After completing the treatment, follow-up visits will be scheduled to monitor long-term health and any delayed side effects.

Who can join the trial?

16 criteria

Must be at least 18 years old.
Must be able to provide written, informed consent and follow the study requirements.
Must have a confirmed diagnosis of uveal melanoma that has spread to other parts of the body.
Must be **HLA-A2 negative**. This means a specific protein is not present in your blood.
Must not have had previous treatments like chemotherapy or immunotherapy for advanced or spreading cancer.
Must have a sample of the tumor available for testing. This can be from a previous surgery or a new biopsy.
Must have at least one tumor that can be measured accurately using a CT or MRI scan.
Must be able to safely receive and absorb the study treatment.
Must have an **ECOG performance status** of 0 or 1, which means you are fully active or have some symptoms but can still do light work.
Must have a life expectancy of at least 3 months.
Must have adequate organ function, which includes:
- A certain level of white blood cells, platelets, and hemoglobin without recent transfusions.
- Normal levels of liver enzymes and bilirubin, unless you have a specific liver condition.
- Normal kidney function.
- Normal blood clotting times unless you are on stable blood-thinning medication.
- Women who can become pregnant must use effective birth control during the study and for 6 months after the last dose.
- Men must be surgically sterile or use double barrier contraception during the study and for 6 months after the last dose.

Who cannot join the trial?

1 criterion

Patients who do not have **HLA-A2 negative metastatic uveal melanoma**. This means the specific type of eye cancer that has spread and does not have a certain genetic marker called HLA-A2.

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Verified sites

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Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium

Trial locations

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Investigated drugs

IDE196 (Darovasertib)
is an investigational medication being studied for its potential to treat metastatic uveal melanoma. It is being tested in combination with another medication to see if it can help slow down the progression of the cancer or improve survival rates.
Crizotinib
is a medication that is used in combination with IDE196 in this trial. It is being studied to see if it can enhance the effects of IDE196 in treating metastatic uveal melanoma by potentially inhibiting cancer cell growth.
Investigator's Choice of Treatment
refers to the standard treatments that doctors may choose for patients with metastatic uveal melanoma. This could include a variety of therapies that are commonly used to manage this type of cancer, depending on the specific needs and conditions of the patient.

What is already known about the treatment

Darovasertib
This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating HLA-A2 negative metastatic uveal melanoma. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication is for use in combination with Crizotinib as a first-line therapy for this specific type of melanoma. At the molecular level, Darovasertib works by inhibiting certain proteins that are involved in the growth and spread of cancer cells. It is classified as a protein kinase inhibitor.
Crizotinib
This medication is also taken orally and is being evaluated in combination with Darovasertib for treating HLA-A2 negative metastatic uveal melanoma. Crizotinib is already approved for use in other types of cancer, but its role in this specific melanoma is still being researched. It is used to target and block specific proteins that contribute to cancer cell growth. Crizotinib is classified as a tyrosine kinase inhibitor.

Investigated diseases

Metastatic Uveal Melanoma – This is a rare type of cancer that originates in the eye's uveal tract, which includes the iris, ciliary body, and choroid. It occurs when melanoma cells spread from the eye to other parts of the body, most commonly the liver. The disease progresses as the cancerous cells grow and form tumors in these new locations. Symptoms may include vision changes, eye pain, or visible changes in the eye, but these can vary depending on the extent and location of the metastasis. As the disease advances, it can lead to further complications depending on the organs affected.