All studies
RecruitingPHASE1, PHASE2INTERVENTIONAL

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.

At a glance

Status
Recruiting
Phase
PHASE1, PHASE2
Sponsor
Scancell Ltd
Enrolment target
168
Start
07 Apr 2022
Estimated completion
01 Jul 2027

What is this study about?

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.

Key takeaways

  • 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.

Who may be eligible?

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.

Quick self-check
  • 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?
  • Am I at least 18 years old?
  • Is my cancer measurable on scans?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

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.

Potential risks and benefits

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
    Brighton, United Kingdom· Active not recruiting
  • Velindre Cancer Centre
    Cardiff, United Kingdom· Recruiting
  • Edinburgh Cancer Centre (NHS Lothian)
    Edinburgh, United Kingdom· Recruiting
  • Royal Surrey NHS Foundation
    Guildford, United Kingdom· Recruiting
  • Imperial College Healthcare NHS Trust
    London, United Kingdom· Active not recruiting
  • Mount Vernon
    London, United Kingdom· Recruiting
  • University College London Hospital NHS Foundation Trust
    London, United Kingdom· Recruiting
  • Christie NHS Foundation Trust
    Manchester, United Kingdom· Recruiting
  • Nottingham University Hospitals Cancer Centre
    Nottingham, United Kingdom· Recruiting
  • Lancashire Teaching Hospitals NHS Foundation Trust
    Preston, United Kingdom· Recruiting
  • Sheffield Teaching Hospital NHS Foundation Trust
    Sheffield, United Kingdom· Recruiting
  • The Royal Marsden NHS Foundation Trust
    Sutton, United Kingdom· Not yet recruiting

+4 more sites — see the official record for the full list.

Common questions

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.

How long will the study last for me?

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

How to find out more

Robert Miller

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Modi-1 Moditope in Breast, Head and Neck, Ovarian, or Renal …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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