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

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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 the medications IDE196 (Darovasertib) and Crizotinib. These medications are being tested as a first-line therapy, which means they are used as the initial treatment for this cancer. The purpose of the study is to determine the best dose of this combination and to compare its effectiveness to other treatments chosen by doctors.

Participants in the study will receive either the combination of IDE196 and Crizotinib or another treatment selected by their doctor, which may include medications like Ipilimumab, Nivolumab, Pembrolizumab, or Dacarbazine. The study will be conducted in phases, starting with Phase 2a to find the optimal dose, followed by Phase 2b and Phase 3 to compare the new treatment with existing options. The study will monitor the progression of the disease and overall survival of the participants.

Throughout the study, participants will be closely observed for any side effects and changes in their health. The trial aims to provide valuable information on how well the new treatment works compared to other available therapies. This research is important for developing better treatment options for patients with metastatic uveal 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.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be required to provide written, informed consent. This ensures understanding and agreement to comply with the study requirements.

    Eligibility will be confirmed based on criteria such as age, health status, and previous treatments.

  2. Step 2

    Phase 2a: dose determination

    The initial phase involves determining the optimal dose of IDE196 (Darovasertib) combined with Crizotinib. This combination is administered orally in tablet form.

    The goal is to establish a recommended dose for subsequent phases.

  3. Step 3

    Phase 2b: treatment comparison

    Participants will receive either the IDE196 and Crizotinib combination or an alternative treatment chosen by the investigator.

    The effectiveness of the treatments will be compared based on progression-free survival, which measures the time until the disease progresses or the participant passes away.

  4. Step 4

    Phase 3: overall survival comparison

    In this phase, the focus is on comparing the overall survival rates between the IDE196 and Crizotinib combination and the investigator's choice of treatment.

    Overall survival is defined as the time from randomization until death from any cause.

  5. Step 5

    Medication administration

    The study involves various medications administered through different routes. IDE196 and Crizotinib are taken orally as tablets.

    Other medications like Ipilimumab, Nivolumab, and Pembrolizumab are given through infusion, while Dacarbazine is administered via intravenous infusion.

  6. Step 6

    Monitoring and assessments

    Participants will undergo regular monitoring to assess the treatment's effects and any side effects. This includes laboratory tests, ECGs, and vital sign checks.

    Progression-free survival and overall survival will be evaluated, along with other response measures.

  7. Step 7

    End of study

    The study is estimated to conclude by December 31, 2027. Participants will be followed up to assess long-term outcomes and any lasting effects of the treatment.

Who can join the trial?

13 criteria

  • Must be at least 18 years old.
  • Must provide written, informed consent before starting any study-related procedures and be able to follow all study requirements.
  • Must have a confirmed diagnosis of metastatic uveal melanoma, which means the cancer has spread from the eye to other parts of the body.
  • Must be **HLA-A*02:01 negative**, which is a specific genetic marker.
  • Must not have had any previous systemic treatments for metastatic or advanced cancer, such as chemotherapy or immunotherapy.
  • Must provide a sample of the tumor tissue for testing, either from a previous surgery or a new biopsy, unless it's not medically possible.
  • 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 being fully active or having some symptoms but still able to carry out light work.
  • Must have a life expectancy of at least 3 months.
  • Must have adequate organ function, which includes specific blood counts and liver and kidney function tests.
  • Women who can become pregnant must use highly effective birth control during the study and for 6 months after the last dose of the study treatment.
  • Men must be surgically sterile or agree to use double barrier contraception methods during the study and for 6 months after the last dose of the study treatment.

Who cannot join the trial?

4 criteria

  • Patients who do not have **HLA-A2 negative metastatic uveal melanoma**. This means the study is only for those with a specific type of eye cancer that has spread to other parts of the body and who have a particular genetic marker called HLA-A2.
  • Patients who are not within the specified age range. The study is open to certain age groups, so if you are outside of these age ranges, you cannot participate.
  • Patients who are not male or female. The study is open to both men and women, so if you do not identify as either, you may not be eligible.
  • Patients who are considered part of a **vulnerable population**. This term refers to groups of people who might be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.
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Investigated drugs

  • IDE196 (Darovasertib)

    is a medication being studied for its potential to treat metastatic uveal melanoma, a type of eye cancer. It is being tested in combination with another drug to see if it can help stop or slow down the growth of cancer cells.

  • Crizotinib

    is a medication that is used in combination with IDE196 in this clinical trial. It is known to target specific proteins in cancer cells, which may help to stop the cancer from growing and spreading. The combination of Crizotinib with IDE196 is being evaluated to determine if it is more effective than other treatments chosen by doctors.

What is already known about the treatment

  • Darovasertib

    Darovasertib is administered orally and is currently being studied in clinical trials for its effectiveness in treating HLA-A2 negative metastatic uveal melanoma. It is in the investigational stage, with ongoing research to determine its optimal dosing and efficacy. The medication works by inhibiting specific proteins involved in cancer cell growth, thereby slowing down or stopping the progression of the disease. It is classified as a protein kinase inhibitor.

  • Crizotinib

    Crizotinib is taken orally and is being evaluated in combination with Darovasertib for the treatment of HLA-A2 negative metastatic uveal melanoma. It is an established medication in oncology, known for its role in treating certain types of lung cancer. Crizotinib functions by blocking the activity of proteins that promote cancer cell growth, specifically targeting abnormal proteins in cancer cells. It belongs to the class of medications known as tyrosine kinase inhibitors.

Investigated diseases

Metastatic Uveal Melanoma – This is a rare type of cancer that originates in the uveal tract of the eye, which includes the iris, ciliary body, and choroid. It is characterized by the spread of cancer cells from the eye to other parts of the body, most commonly the liver. The disease progresses as the cancerous cells invade surrounding tissues and organs, leading to the formation of secondary tumors. Symptoms may include changes in vision, eye pain, or visible changes in the eye, although these can vary depending on the extent and location of metastasis. As the disease advances, it can affect the function of the organs involved, particularly if the liver is affected.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-506686-66-01Protocol codeIDE196-002Estimated enrolment420 patientsSponsorIdeaya Biosciences Inc.

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