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Ativo, mas não recrutandoFASE2, FASE3INTERVENCIONISTA

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.

Em resumo

Status
Ativo, mas não recrutando
Fase
FASE2, FASE3
Patrocinador
IDEAYA Biosciences
Meta de inscrição
420
Iniciar
31 Out 2023
Conclusão estimada
15 Jan 2028

Sobre o que é este estudo?

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.

Pontos principais

  • 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.

Quem pode ser elegível?

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.

Este estudo pode ser adequado para você?

Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.

  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. Você está se sentindo bem de modo geral e consegue realizar as atividades diárias?
  4. Are you able to take study medicines safely?
  5. Você não está grávida ou amamentando atualmente?
  6. Do you have good overall organ health (e.g., heart, kidneys, liver)?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

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.

Riscos e benefícios potenciais

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.

Localizações (68)

  • Honor Health
    Código postal verificado
    Scottsdale, Estados Unidos
  • Moores Cancer Center
    Código postal verificado
    La Jolla, Estados Unidos
  • Centro Médico da UCLA
    Código postal verificado
    Los Angeles, Estados Unidos
  • The Angeles Clinic and Research Institute
    Código postal verificado
    Los Angeles, Estados Unidos
  • California Pacific Medical Center (CPMC)
    Código postal verificado
    São Francisco, Estados Unidos
  • Universidade da Califórnia, São Francisco
    Código postal verificado
    São Francisco, Estados Unidos
  • University of Colorado Cancer Center
    Código postal verificado
    Aurora, Estados Unidos
  • SCRI at HealthONE
    Código postal verificado
    Denver, Estados Unidos
  • University of Miami Sylvester Comprehensive Cancer Center
    Código postal verificado
    Miami, Estados Unidos
  • Centro de Câncer Moffitt
    Código postal verificado
    Tampa, Estados Unidos
  • Northside Hospital Atlanta
    Código postal verificado
    Atlanta, Estados Unidos
  • Universidade de Iowa
    Código postal verificado
    Iowa City, Estados Unidos

Perguntas frequentes

What is metastatic uveal melanoma?

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

O que significa 'atribuído aleatoriamente'?

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

Saberei qual tratamento estou recebendo?

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.

Posso parar de participar se eu quiser?

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

Como saber mais

Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.

Discussão

Discussão da comunidade

Desenvolvido pelo nosso fórum em community.patient.info. Por favor, seja respeitoso — isto não é um conselho médico.