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Ativo, mas não recrutandoFASE2INTERVENCIONISTA

Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

This research trial, called ASPEN-03, is investigating a new treatment approach for advanced head and neck squamous cell carcinoma (a type of head and neck cancer). It combines a new drug called evorpacept with an already approved cancer drug, pembrolizumab. The main goal is to find out if this combination therapy is more effective at fighting the cancer than pembrolizumab on its own. This study is for people whose cancer has spread or returned and cannot be removed by surgery, and who have not yet received treatment for this advanced stage of their disease. Researchers will compare patients receiving the new combination with those receiving pembrolizumab only to see which treatment works best. It's a Phase 2 trial, which means it’s still in the early stages of testing for effectiveness and safety. Participants will be aged 18 or older.

Em resumo

Status
Ativo, mas não recrutando
Fase
FASE2
Patrocinador
ALX Oncology Inc.
Meta de inscrição
189
Iniciar
02 Apr 2021
Conclusão estimada
30 Jun 2026

Sobre o que é este estudo?

This clinical trial is designed for people with a type of head and neck cancer called squamous cell carcinoma, which has either spread to other parts of the body (metastatic) or has come back after treatment and can't be surgically removed (unresectable, recurrent). The study is specifically looking at patients who haven't received any treatment yet for this advanced stage of their cancer.

The main idea behind this study is to test a new drug, evorpacept, when given together with pembrolizumab, which is a common cancer medication. Doctors want to see if this combination works better than pembrolizumab alone in shrinking the cancer or stopping it from growing. Pembrolizumab works by helping your body's immune system fight cancer cells, and evorpacept is designed to help this process even further.

This is a Phase 2 study, which means it's one of the earlier steps in testing new treatments. It focuses on how well the treatment works against the cancer and also continues to check for safety. A small group of patients will first receive the combined treatment to ensure it's safe. After that, more patients will be randomly assigned to either receive the combination treatment or pembrolizumab on its own, so doctors can directly compare the two approaches. This helps researchers understand if adding evorpacept provides a meaningful benefit.

Pontos principais

  • This study is for advanced head and neck cancer that hasn't been treated yet.
  • It tests a new drug, evorpacept, combined with an existing one, pembrolizumab.
  • The goal is to see if the combination works better than pembrolizumab alone.
  • It's a Phase 2 trial, focusing on effectiveness and safety.
  • Participants must be 18 or older and meet specific health requirements.

Quem pode ser elegível?

To be able to join this study, you would generally need to have head and neck squamous cell carcinoma that has either spread or come back after previous treatment and can't be removed by surgery. Importantly, you shouldn't have received any other treatments for this advanced stage of your cancer yet. Your cancer also needs to show certain features that indicate it might respond to the treatments being studied.

Your general health is also important. This includes having healthy bone marrow (which makes blood cells), good kidney and liver function, and a good overall physical ability to carry out daily activities. You must be at least 18 years old to participate.

There are also some reasons why you wouldn't be able to join. For example, if your cancer has spread to your brain and is causing severe symptoms, or if you have a history of certain lung problems that needed strong medication. Also, if you've previously been treated with similar types of immune-boosting drugs that are being tested in this trial, you wouldn't be able to take part.

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. I have advanced head and neck squamous cell carcinoma.
  2. My cancer has spread or returned and cannot be surgically removed.
  3. I have not received any treatment yet for my advanced cancer.
  4. I am at least 18 years old.
  5. My general health, including blood, kidney, and liver function, is considered good by my doctor.
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

If you decide to take part, you'll first go through some screening tests to see if the study is right for you. If you qualify, you'll be randomly assigned to one of two groups: either you'll receive the new drug evorpacept plus pembrolizumab, or you'll receive pembrolizumab alone. This is like flipping a coin – neither you nor the doctors decide which group you're in, which helps make the study fair.

The treatments will be given through injections or infusions, typically at a clinic or hospital. You'll have regular visits for blood tests, physical exams, and scans (like CT or MRI) to check how you're responding to the treatment and to monitor for any side effects. The study involves ongoing treatment and visits as long as the treatment is working and you are tolerating it well. After you stop treatment, there will be follow-up visits or calls to monitor your health over a longer period. The total duration of your involvement could vary depending on your response to treatment and the follow-up schedule.

Riscos e benefícios potenciais

Taking part in a clinical trial may offer potential benefits, such as access to new treatments before they are widely available, and close monitoring by a medical team. For this study, there's a chance the combination treatment might be more effective than standard care for your type of cancer. However, there are also potential risks; new drugs can have side effects that aren't fully known, and some treatments might not work for everyone. You might experience side effects from either evorpacept or pembrolizumab, or a combination of both. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Localizações (53)

  • Hoag Hospital
    Código postal verificado
    Irvine, Estados Unidos
  • Universidade da Califórnia San Diego
    Código postal verificado
    La Jolla, Estados Unidos
  • H. Lee Moffitt Cancer Center
    Código postal verificado
    Tampa, Estados Unidos
  • Northwest Georgia Oncology Centers
    Código postal verificado
    Marietta, United States
  • Centro Médico da Universidade Rush
    Código postal verificado
    Chicago, Estados Unidos
  • Blessing Cancer Center
    Código postal verificado
    Quincy, United States
  • University of Maryland Medical System
    Código postal verificado
    Baltimore, Estados Unidos
  • Hospital Geral de Massachusetts
    Código postal verificado
    Boston, Estados Unidos
  • Rutgers Cancer Institute of New Jersey
    Código postal verificado
    Newark, Estados Unidos
  • Memorial Sloan-Kettering Cancer Center
    Código postal verificado
    Long Island City, United States
  • The Ohio State University
    Código postal verificado
    Columbus, Estados Unidos
  • Oregon Health & Science University
    Código postal verificado
    Portland, Estados Unidos

Perguntas frequentes

O que é carcinoma de células escamosas de cabeça e pescoço?

It's a common type of cancer that starts in the moist lining inside the head and neck, such as the mouth, throat, or voice box.

What does 'advanced' cancer mean in this study?

It means the cancer has either spread to other parts of your body or has returned after initial treatment and cannot be removed by surgery.

What is the new drug, evorpacept?

Evorpacept is a new investigational drug designed to help your immune system recognise and fight cancer cells more effectively when used with other treatments.

What is pembrolizumab?

Pembrolizumab is an approved medication that works by helping your body's own immune system find and kill cancer cells. It's often used for certain advanced cancers.

What does 'Phase 2' trial mean?

Phase 2 means the study is in an earlier stage of testing, mainly focused on seeing if the treatment works well against the cancer and continuing to check for safety.

Como saber mais

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

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