Safety and Efficacy of VB10.16 and Pembrolizumab in Patients With Head-Neck Squamous Cell Carcinoma
This research study is looking for adults in the UK with a specific type of head and neck cancer called oropharyngeal squamous cell carcinoma, which has spread or come back after treatment and is linked to the HPV16 virus. This cancer can't be removed by surgery. The study aims to find the right dose of a new treatment, VB10.16, which acts like a vaccine to help your body fight the cancer. VB10.16 will be given alongside pembrolizumab, a standard treatment that helps your immune system work better. Researchers will check safety, side effects, and how well the treatment shrinks the cancer. This information will help plan future studies.
Em resumo
Sobre o que é este estudo?
This research study is designed for individuals in the UK who have a certain type of head and neck cancer called oropharyngeal squamous cell carcinoma. This cancer is specifically linked to the HPV16 virus and has either spread to other parts of the body or has returned after previous treatments, and doctors believe it cannot be cured with surgery. The main aim of this study is to explore a new treatment called VB10.16, which is an 'investigational therapeutic DNA vaccine.' This means it's a new type of medicine designed to help your body's immune system recognise and fight the cancer cells. It's not like a vaccine that prevents you from getting a disease, but rather one that helps treat an existing disease.
VB10.16 will be given alongside another medicine called pembrolizumab, which is already a standard treatment for some people with this type of cancer. Pembrolizumab works by helping your immune system to better attack cancer cells. The study is split into two parts: the first part will involve testing three different doses of VB10.16 with a standard dose of pembrolizumab. This helps researchers find the safest and most effective dose of VB10.16 to use. In the second part, participants will receive this chosen dose of VB10.16, or sometimes a slightly different dose, along with pembrolizumab.
The overall goal is to understand how safe and well-tolerated the combination of VB10.16 and pembrolizumab is, and to see if it helps shrink the cancer. The information gathered from this study will be crucial in deciding if and how these treatments should be studied further for people with this type of cancer in the future.
Pontos principais
- The study is for advanced head and neck cancer linked to HPV16.
- It tests a new 'vaccine-like' drug (VB10.16) with a standard treatment (pembrolizumab).
- Its main goal is to find the safest and best dose of VB10.16.
- Participation involves regular hospital visits for treatment and checks.
- You can leave the study at any time without affecting your care.
Quem pode ser elegível?
To join this study, you need to be at least 18 years old and have a specific type of head and neck cancer. This cancer must be in the oropharynx (part of your throat behind your mouth), be linked to the HPV16 virus, and have either spread or come back after initial treatment, meaning it can't be cured by surgery alone. Your doctors must also think that pembrolizumab, one of the study drugs, would be a suitable treatment for you.
Your general health is also important. Doctors will check that your main body organs, like your kidneys, liver, and blood, are working well enough for you to take part. You'll have blood tests to check things like your blood cell counts, and your overall fitness will be assessed. If you are a woman who could become pregnant, you'll need to have a negative pregnancy test before starting.
There are also specific medical conditions or treatments that might mean you can't join the study. These can include certain other health problems or medications that could interact with the study drugs. The study team will review all your medical information carefully to make sure it's safe for you to participate.
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.
- Você tem 18 anos ou mais?
- Do you have HPV16-positive head and neck cancer that has spread or returned?
- Is your cancer in the oropharynx (part of the throat)?
- Are your kidney, liver, and blood test results generally healthy?
- Are you able to visit the hospital regularly for treatments and check-ups?
O que envolve a participação?
If you decide to take part in this study, you will receive two types of medicine: VB10.16 and pembrolizumab. The VB10.16 will be given by an injection, and pembrolizumab will be given through a drip into your vein. Doctors will carefully monitor your health and response throughout the study.
The study involves regular visits to the hospital for treatments, blood tests, and check-ups to see how you are doing and to monitor for any side effects. These visits will be more frequent at the beginning and then might become less often over time, but you should expect to attend regularly for about a year. During these visits, doctors will also check the size of your cancer to see if the treatment is working.
After about a year of receiving both treatments, if your doctor and the study team agree, you might continue to receive pembrolizumab alone for a longer period. The total duration of your participation will depend on how you respond to the treatment and the study plan, but you will be kept informed every step of the way.
Riscos e benefícios potenciais
Locations (12)
- CRLC Val d'Aurelle - Institut de Recherche en Cancerologie de Montpellier (IRCM)Código postal verificadoMontpellier, France· Recrutamento
- Institut Gustave RoussyCódigo postal verificadoParis, França· Recrutamento
- Universitaetsklinikum Giessen und Marburg GmbH - Klinik fuer Hals, Nasen- und OhrenheilkundeCódigo postal verificadoGiessen, Germany· Recrutamento
- National Institute of OncologyCódigo postal verificadoBudapest, Hungary· Recrutamento
- University of Bergen, Haukeland University HospitalCódigo postal verificadoBergen, Norway· Recrutamento
- Oslo UniversitetssykehusCódigo postal verificadoOslo, Norway· Recrutamento
- Uniwersyteckie Cetrum KliniczneCódigo postal verificadoGdansk, Polônia· Recrutamento
- Narodowy Instytut Onkologii-im Marii Sklodowskiej-Curie Panstwowy InstytutCódigo postal verificadoGliwice, Poland· Recrutamento
- Hospital del MarCódigo postal verificadoBarcelona, Espanha· Recrutamento
- ICO Hospitalet (Hospital Duran i Reynals)Código postal verificadoBarcelona, Espanha· Recrutamento
- Centro de Câncer MD AndersonCódigo postal verificadoMadrid, Espanha· Recrutamento
- East and North Hertfordshire NHS Trust Mount Vernon HospitalCódigo postal verificadoLondres, Reino Unido· Recrutamento
Perguntas frequentes
What is HPV16-positive head and neck cancer?
It's a type of cancer in the throat area (oropharynx) that is caused by the Human Papillomavirus type 16 (HPV16).
What is VB10.16?
VB10.16 is a new type of treatment, similar to a vaccine, designed to help your body's immune system fight cancer cells caused by HPV16.
What is pembrolizumab?
Pembrolizumab is an existing medicine that boosts your own immune system to help it attack cancer cells. It's often used for advanced cancers.
Will I know which dose of VB10.16 I'm getting?
In the second part of the study, the dose you receive will be chosen randomly, so you might not know which specific dose you are getting at that time.
Quanto tempo estarei no estudo?
You will receive both study drugs for about 48 weeks, and then you might continue with pembrolizumab alone depending on how you are doing and your doctor's advice.
Como saber mais
Chief Medical Officer
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