Tutti gli studi
ReclutamentoFASE1, FASE2INTERVENTISTICO

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.

A colpo d'occhio

Stato
Reclutamento
Fase
FASE1, FASE2
Sponsor
Scancell Ltd
Obiettivo di iscrizione
168
Inizio
07 Apr 2022
Completamento stimato
01 Jul 2027

Di cosa tratta questo studio?

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.

Punti chiave

  • 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.

Chi può essere idoneo?

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.

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.

  1. Do I have advanced triple negative breast, head and neck, high-grade ovarian, or kidney cancer?
  2. Has my cancer spread or is it not treatable with surgery for cure?
  3. Have I already received, or cannot have, standard treatments for my cancer?
  4. Ho almeno 18 anni?
  5. Is my cancer measurable on scans?
Rispondi a ogni domanda per vedere il tuo risultato.

Cosa comporta la partecipazione?

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.

Rischi e benefici potenziali

Participating in a clinical trial may offer potential benefits, such as gaining access to a new treatment that isn't widely available. While the Modi-1 Moditope vaccine is designed to help your immune system fight cancer, there's no guarantee it will be effective for you. There are potential risks, as with any new medicine, including side effects from the vaccine or the combined treatments. These side effects will be carefully monitored, and the research team will explain them to you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (16)

  • Brighton and Sussex University Hospital
    Codice postale verificato
    Brighton, Regno Unito· Attivo ma non reclutante
  • Velindre Cancer Centre
    Codice postale verificato
    Cardiff, Regno Unito· Reclutamento
  • Edinburgh Cancer Centre (NHS Lothian)
    Codice postale verificato
    Edimburgo, Regno Unito· Reclutamento
  • Royal Surrey NHS Foundation
    Codice postale verificato
    Guildford, United Kingdom· Reclutamento
  • Imperial College Healthcare NHS Trust
    Codice postale verificato
    Londra, Regno Unito· Attivo ma non reclutante
  • Mount Vernon
    Codice postale verificato
    Londra, Regno Unito· Reclutamento
  • University College London Hospital NHS Foundation Trust
    Codice postale verificato
    Londra, Regno Unito· Reclutamento
  • Christie NHS Foundation Trust
    Codice postale verificato
    Manchester, Regno Unito· Reclutamento
  • Nottingham University Hospitals Cancer Centre
    Codice postale verificato
    Nottingham, Regno Unito· Reclutamento
  • Lancashire Teaching Hospitals NHS Foundation Trust
    Codice postale verificato
    Preston, United Kingdom· Reclutamento
  • Sheffield Teaching Hospital NHS Foundation Trust
    Codice postale verificato
    Sheffield, Regno Unito· Reclutamento
  • La Fondazione NHS Royal Marsden
    Codice postale verificato
    Sutton, United Kingdom· Non ancora in fase di reclutamento

Domande comuni

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.

Quanto durerà lo studio per me?

The exact length varies for each person and depends on your treatment schedule and how long you need monitoring.

Come saperne di più

Robert Miller

Parla sempre con il tuo medico di base o specialista prima di decidere di partecipare a uno studio.

Interessato a partecipare?

Registrati per ricevere aggiornamenti

Condividi i tuoi dettagli e il team di ricerca per "Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal …" ti contatterà se potresti essere idoneo. Parla sempre con il tuo medico prima di accettare di partecipare.

Discussione

Discussione della comunità

Supportato dal nostro forum su community.patient.info. Si prega di essere rispettosi — questo non è un consiglio medico.