A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy
This research is looking at a new medicine called volrustomig for people who have a specific type of head and neck cancer. This cancer is locally advanced, meaning it’s grown in the area but hasn’t spread to other parts of the body, and it wasn't removed with surgery. Participants in the study have already completed their main treatment, which includes chemotherapy combined with radiotherapy. The main goal is to find out if volrustomig is effective and safe in helping to stop the cancer from getting worse or coming back, compared to just regular check-ups. The study will carefully watch how participants respond to the medicine and check for any side effects.
A colpo d'occhio
Di cosa tratta questo studio?
This study is about a type of cancer that starts in the head or neck area, specifically called 'squamous cell carcinoma.' This cancer is considered 'locally advanced,' which means it has grown into nearby tissues but hasn't spread to other distant parts of the body. For these patients, the standard treatment often involves a combination of chemotherapy and radiotherapy, given together. This treatment is called 'chemoradiotherapy' and is given with the aim of curing the cancer.
The researchers want to see if adding a new medicine, called volrustomig, to the treatment plan can help. After patients have finished their initial chemoradiotherapy treatment and if their cancer hasn't progressed (meaning it hasn't gotten worse), they might be eligible to join this study. The study will compare volrustomig to simply observing patients, which means they would have regular check-ups without taking the new medicine.
The main purpose is to find out two things: first, how well volrustomig works to prevent the cancer from returning or getting worse, and second, whether it is safe to use. This information will help doctors understand if volrustomig could be a useful new treatment option for people with this type of head and neck cancer.
Punti chiave
- This study tests a new medicine for certain head and neck cancers.
- It's for people who've completed standard chemotherapy and radiotherapy.
- The goal is to see if the new medicine stops cancer from returning.
- You might receive the new medicine or have observation.
- Regular visits and checks are part of participating.
Chi può essere idoneo?
To be part of this study, you must have a specific type of head and neck cancer known as 'squamous cell carcinoma.' This cancer needs to be in certain areas like the throat, voice box, or inside of the mouth, and it should be 'locally advanced,' meaning it hasn't spread to other parts of your body. Importantly, the hospital doctors must have confirmed that your cancer could not be removed by surgery.
You also need to have already finished your main treatment for this cancer, which involved a combination of chemotherapy and radiotherapy at the same time. The goal of that treatment would have been to cure your cancer, and your cancer should not have gotten worse since then.
There are also reasons why you might not be able to join. For example, if your head and neck cancer started in other areas not listed, or if you had more than one main cancer. You also can't join if your cancer was removed by surgery before your chemotherapy and radiotherapy, or if your cancer has come back or was only treated with radiotherapy alone.
Questo studio potrebbe fare al caso tuo?
Rispondi a queste domande rapide per vedere se potresti essere idoneo. Questo è solo una guida — il team di ricerca prende la decisione finale.
- Do you have locally advanced squamous cell carcinoma of the head or neck?
- Was your cancer in the throat, voice box, or inside the mouth?
- Did you complete combined chemotherapy and radiotherapy for your cancer?
- Has your cancer not gotten worse since your main treatment?
- Was your cancer treated without surgery first?
- Hai 18 anni o più?
Cosa comporta la partecipazione?
If you decide to join this study, you would first go through some checks to make sure you're eligible. If you are, you would then start receiving the study medicine, volrustomig, or be in the observation group. This medicine is given as a drip into your arm (intravenous infusion). The study involves regular visits to the clinic for assessments, which will include blood tests, scans, and physical examinations to see how you are responding to the treatment and to check for any side effects. You will be closely monitored by the study team. The total duration of your participation in the study, including the treatment and follow-up period, will be explained in detail by the study doctor.
Rischi e benefici potenziali
Locations (306)
- Sito di RicercaCodice postale verificatoBirmingham, Stati Uniti· Reclutamento
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- Sito di RicercaCodice postale verificatoPrescott Valley, United States· Attivo ma non reclutante
- Sito di RicercaCodice postale verificatoSpringdale, Stati Uniti· Ritirato
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- Sito di RicercaCodice postale verificatoLos Angeles, Stati Uniti· Reclutamento
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- Sito di RicercaCodice postale verificatoSanta Rosa, Stati Uniti· Reclutamento
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- Sito di RicercaCodice postale verificatoColorado Springs, Stati Uniti· Reclutamento
Domande comuni
What is 'locally advanced head and neck squamous cell carcinoma'?
This is a type of cancer that starts in the head or neck, like in the throat or mouth. 'Locally advanced' means it has grown into nearby tissues but hasn't spread to distant parts of the body.
What is 'chemoradiotherapy'?
This is a standard way to treat some cancers, where chemotherapy drugs (strong medicines to kill cancer cells) and radiotherapy (using high-energy rays) are given at the same time.
What is volrustomig?
Volrustomig is the new medicine being tested in this study. Researchers want to see if it can help prevent cancer from coming back after standard treatment.
Riceverò sicuramente il nuovo medicinale?
No, not everyone will get the new medicine. Some participants will receive volrustomig, while others will be in an 'observation' group, meaning they will have regular check-ups without the study medicine.
Quanto dura lo studio?
The total time you spend in the study, including treatment and follow-up, will be explained by the study doctor, as it can vary for each person.
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