All studies
Active not recruitingPHASE2, PHASE3INTERVENTIONAL

IDE196 (Darovasertib) in Combination With Crizotinib as First-line Therapy in Metastatic Uveal Melanoma

This research study is investigating new ways to treat a type of cancer called metastatic uveal melanoma, which is eye melanoma that has spread to other parts of the body. The study aims to see if a new drug combination, IDE196 plus crizotinib, is more effective and safer than currently available treatments. Participants will be randomly assigned to receive either the new drug combination or one of the standard treatments chosen by their doctor. The study will carefully check how well the treatments shrink the cancer, how long people live, and any side effects they experience. This information will help doctors understand the best ways to care for patients with this condition.

At a glance

Status
Active not recruiting
Phase
PHASE2, PHASE3
Sponsor
IDEAYA Biosciences
Enrolment target
420
Start
31 Oct 2023
Estimated completion
15 Jan 2028

What is this study about?

This study is for people who have metastatic uveal melanoma, which is a type of eye cancer that has spread to other parts of the body. When cancer spreads, it can be more challenging to treat, so doctors are always looking for new and better options. This research is testing a new approach using a combination of two drugs, IDE196 and crizotinib. They want to see if this combination works better and is safer than some of the treatments doctors currently offer.

To do this, the study will compare the new drug combination with standard treatments like pembrolizumab, ipilimumab plus nivolumab, or dacarbazine. Patients taking part will be randomly assigned to one of these treatment groups. This random assignment helps ensure the study results are fair and reliable. The study is split into different stages (Phase 2 and Phase 3) to gradually gather information. First, they'll find the best dose of the new drug combination, and then they'll compare that dose more widely against the standard treatments.

The main goal is to find out if the new drug combination helps people live longer and if it can shrink the cancer effectively, all while keeping side effects manageable. By carefully comparing these different treatments, researchers hope to improve the care options available for people with metastatic uveal melanoma.

Key takeaways

  • This study is for advanced eye melanoma that has spread.
  • It tests a new drug combination against usual treatments.
  • Participation involves regular check-ups, blood tests, and scans.
  • You'll be randomly assigned to a treatment group.
  • The goal is to find better, safer treatments for this cancer.

Who may be eligible?

To be considered for this study, you would need to have a confirmed diagnosis of eye melanoma that has spread. Importantly, you shouldn't have received any previous treatment specifically for this advanced cancer, though some earlier treatments like surgery or radiation in a local area might be allowed.

Your general health would also be checked, including your organ function and overall well-being. You would need to be well enough to take the study medication and have a life expectancy of at least three months. There is also a specific blood test for something called HLA-A*02:01, and you would need to be negative for this marker.

Some things that might prevent you from joining include a history of other serious health conditions like certain heart problems, active infections, or if you've already had a similar type of drug. If you are pregnant or breastfeeding, you wouldn't be able to take part. The study also needs to make sure the standard treatments chosen by your doctor are suitable for you, so any reasons you couldn't take those would also be a factor.

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.

  1. Do you have eye melanoma that has spread to other parts of your body?
  2. Have you not had any treatment specifically for this spread cancer before?
  3. Are you generally feeling well and able to carry out daily activities?
  4. Are you able to take study medicines safely?
  5. Are you not currently pregnant or breastfeeding?
  6. Do you have good overall organ health (e.g., heart, kidneys, liver)?
Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to receive either the new drug combination (IDE196 + crizotinib) or one of the standard treatments chosen by your doctor. You won't get to choose which treatment you receive. You will have regular visits to the clinic for medical check-ups, blood tests, and scans (like CT or MRI) to see how your body is responding to the treatment and if the cancer is changing. These visits will also help monitor for any side effects. The medications will be given according to a specific schedule, which your study team will explain in detail. The total duration of your participation will depend on how you respond to the treatment and the study's design, but it will involve ongoing follow-up to monitor your health.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. You might benefit from receiving a new treatment that isn't widely available yet, which could be more effective for your condition. However, there's no guarantee the new treatment will work for you, and it might have side effects that are unknown or more severe than standard treatments. You might also experience side effects from the standard treatments. Your doctor and the study team will monitor you closely for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (68)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Honor Health
    Verified postcode
    Scottsdale, United States
  • Moores Cancer Center
    Verified postcode
    La Jolla, United States
  • UCLA Medical Center
    Verified postcode
    Los Angeles, United States
  • The Angeles Clinic and Research Institute
    Verified postcode
    Los Angeles, United States
  • California Pacific Medical Center (CPMC)
    Verified postcode
    San Francisco, United States
  • University of California San Francisco
    Verified postcode
    San Francisco, United States
  • University of Colorado Cancer Center
    Verified postcode
    Aurora, United States
  • SCRI at HealthONE
    Verified postcode
    Denver, United States
  • University of Miami Sylvester Comprehensive Cancer Center
    Verified postcode
    Miami, United States
  • Moffitt Cancer Center
    Verified postcode
    Tampa, United States
  • Northside Hospital Atlanta
    Verified postcode
    Atlanta, United States
  • University of Iowa
    Verified postcode
    Iowa City, United States

Common questions

What is metastatic uveal melanoma?

It's a type of eye cancer that has spread from the eye to other parts of your body.

What does 'randomly assigned' mean?

It means you'll be put into a treatment group by chance, like flipping a coin, so the study is fair.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, meaning both you and your doctor will know which treatment you are receiving.

What are 'Phase 2' and 'Phase 3' studies?

Phase 2 studies check if a new treatment works and is safe. Phase 3 studies compare it to existing treatments to see if it's better.

Can I stop participating if I want to?

Yes, you can leave the study at any time, and it won't affect your regular medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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