Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal Cancer
This research is looking into a new treatment called Modi-1 Moditope for people with specific advanced cancers: triple negative breast cancer, head and neck cancer, a type of ovarian cancer, or kidney cancer. The main goals are to check if the Modi-1 Moditope vaccine is safe, how well people tolerate it, and if it helps the body's immune system fight cancer. It will be tested on its own and also together with an existing cancer medicine called pembrolizumab, or similar drugs, that help the immune system. For some head and neck cancer patients, it will also be studied before surgery. The vaccine is given through a special small device on the skin.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
This study is exploring a new treatment called Modi-1 Moditope for certain types of advanced cancer. These include triple negative breast cancer, some head and neck cancers, a specific type of ovarian cancer, and kidney cancer. Cancer treatments are always improving, and one promising area is immunotherapy, which helps your body's own immune system fight cancer cells. Modi-1 Moditope is designed to be a vaccine that 'teaches' your immune system to better recognise and attack cancer cells that have certain markers.
The researchers want to find out several things: first, is Modi-1 Moditope safe to use, and how well do people tolerate it? They also want to see if it boosts the immune system to fight cancer and if it shows early signs of shrinking tumours or stopping their growth. This vaccine will be given either by itself or alongside other established immunotherapy drugs, such as pembrolizumab. These combined treatments are often used when the cancer has spread or can't be removed by surgery.
For a specific group of head and neck cancer patients who are planning to have surgery, the study will also look at using Modi-1 Moditope (with or without pembrolizumab) before their operation. A small device called NanoPass, which has tiny needles, will be used to give the Modi-1 Moditope treatment just under the skin. This study aims to involve about 168 people across various hospitals in the UK, making sure to carefully check the effects and benefits of this new approach.
النقاط الرئيسية
- Tests a new vaccine (Modi-1 Moditope) for advanced cancers.
- Aims to check safety, tolerability, and how it boosts the immune system.
- Could be given alone or with other immunotherapy drugs.
- Administered under the skin with a special small device.
- Involves regular check-ups and monitoring.
- For certain breast, head and neck, ovarian, or kidney cancers.
من قد يكون مؤهلاً؟
To be considered for this study, you would need to have one of the following types of advanced cancer: triple negative breast cancer, head and neck cancer, a type of ovarian cancer (high-grade serous), or kidney cancer. For these conditions, the cancer should ideally not be treatable with surgery aiming for a cure. If you have head and neck cancer, you might also be eligible if you are planned to have surgery that aims to cure your cancer.
Additionally, you should have already received, or not be suitable for, standard treatments for your specific cancer type. For example, some breast cancer patients might have finished their standard treatments or refused them, or stopped immunotherapy due to side effects. For head and neck cancer, you might have had chemotherapy with or without radiotherapy, or be unable to have platinum-based chemotherapy. The study will look for patients whose disease can be measured by medical scans.
The study welcomes both men and women, and you need to be at least 18 years old. These are general guidelines, and the full details will be discussed with you by the study doctor to see if this trial is a good fit for your individual situation.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- Do I have advanced triple negative breast, head and neck, high-grade ovarian, or kidney cancer?
- Has my cancer spread or is it not treatable with surgery for cure?
- Have I already received, or cannot have, standard treatments for my cancer?
- هل عمري لا يقل عن 18 عامًا؟
- Is my cancer measurable on scans?
ماذا يتضمن المشاركة؟
If you join this study, you will receive the Modi-1 Moditope treatment, which will be given using a special small device called NanoPass that delivers the treatment just under the skin. Depending on which part of the study you are in, you might receive Modi-1 Moditope by itself or together with other approved cancer drugs like pembrolizumab, which might be given through a drip. The exact schedule of your visits and treatments will depend on your condition and the specific arm of the study you are in, but it will involve regular appointments for treatment, assessments, and check-ups.
These assessments will include physical examinations, blood tests, and scans to monitor your cancer and check how you are responding to the treatment. The research team will also be looking at how your immune system responds to the vaccine. There will be follow-up appointments after your treatment period to see how you are doing in the long term. The total duration of your participation will vary but will include active treatment phases and monitoring periods.
المخاطر والفوائد المحتملة
المواقع (16)
- Brighton and Sussex University Hospitalالرمز البريدي المؤكدبرايتون، المملكة المتحدة· نشط غير مجند
- Velindre Cancer Centreالرمز البريدي المؤكدكارديف، المملكة المتحدة· التوظيف
- Edinburgh Cancer Centre (NHS Lothian)الرمز البريدي المؤكدإدنبرة، المملكة المتحدة· التوظيف
- Royal Surrey NHS Foundationالرمز البريدي المؤكدGuildford, United Kingdom· التوظيف
- مؤسسة الرعاية الصحية لكلية إمبريال التابعة لهيئة الخدمات الصحية الوطنيةالرمز البريدي المؤكدلندن، المملكة المتحدة· نشط غير مجند
- Mount Vernonالرمز البريدي المؤكدلندن، المملكة المتحدة· التوظيف
- University College London Hospital NHS Foundation Trustالرمز البريدي المؤكدلندن، المملكة المتحدة· التوظيف
- Christie NHS Foundation Trustالرمز البريدي المؤكدمانشستر، المملكة المتحدة· التوظيف
- Nottingham University Hospitals Cancer Centreالرمز البريدي المؤكدنوتنغهام، المملكة المتحدة· التوظيف
- Lancashire Teaching Hospitals NHS Foundation Trustالرمز البريدي المؤكدPreston, United Kingdom· التوظيف
- Sheffield Teaching Hospital NHS Foundation Trustالرمز البريدي المؤكدشيفيلد، المملكة المتحدة· التوظيف
- مؤسسة رويال مارسدن التابعة لهيئة الخدمات الصحية الوطنيةالرمز البريدي المؤكدساتون، المملكة المتحدة· لم يبدأ التوظيف بعد
أسئلة شائعة
What is Modi-1 Moditope?
It's a new type of vaccine designed to help your body's immune system recognise and fight certain cancer cells.
What cancers is this study for?
It's for specific advanced cancers: triple negative breast, head and neck (squamous cell), high-grade ovarian serous, or kidney (renal cell) cancer.
How is the Modi-1 Moditope given?
It's given just under the skin using a special small device with tiny needles called NanoPass.
Can I get this treatment on its own?
Yes, in some parts of the study, Modi-1 Moditope is given by itself, and in others, it's combined with another cancer drug.
كم ستستغرق الدراسة بالنسبة لي؟
The exact length varies for each person and depends on your treatment schedule and how long you need monitoring.
كيفية معرفة المزيد
Robert Miller
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
هل أنت مهتم بالمشاركة؟
نقاش
مناقشة المجتمع
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