Overview

The ModiFY Study is a clinical trial and oncologists across the UK are recruiting patients with Head and Neck, Renal Cell, and Triple Negative Breast Cancer.

The study will research a new immunotherapy called Modi-1, to see if it can be used safely in these advanced cancers. Modi-1 is a vaccine that contains three peptides. Peptides are small parts of a protein designed to help your immune system fight cancer.

Modi-1 will be administered alone or in combination with checkpoint inhibitors (CPIs).

The ModiFY Study investigates the Modi-1 vaccine and is designed to explore its safety, whether it triggers your body’s immune system to fight your cancer (immunological activity) and how effective the vaccine is (preliminary efficacy) when given to patients with advanced solid tumours, specifically those with Head and Neck, Renal Cell and Triple Negative Breast cancer.

The short video provides more information about the ModiFY study

ModiFY Participant Information Animation

The ModiFY Study...is recruiting patients with triple negative breast, head and neck, ovarian or kidney cancers.

The study will investigate a new immunotherapy, called Modi-1, to see if it can be used safely in these advanced cancers.

Modi-1 is a vaccine that contains three peptides. Peptides are small parts of a protein designed to help your immune system fight cancer.

This is an experimental treatment that may help treat your cancer by triggering an immune response so that your immune system can shrink your tumour.

As with all drugs there are potential side effects, so your study doctor will monitor you closely throughout the study.

The ModiFY Study is recruiting approximately 138 patients in up to 20 cancer centres across the UK.

Patients with your type of cancer are invited to participate…if your doctor believes you are eligible for this type of immunotherapy.

If you are currently receiving a course of checkpoint inhibitors these will continue as planned.

Your doctor will provide you with more information about the study…and if you decide to take part will ask you to sign a consent form.

Taking part in the study is voluntary. You are free to withdraw at any time without giving a reason

If you do withdraw, or don’t want to take part, you are still offered the same standard of care for your cancer.

All patients enrolled in the study complete a number of screening examinations for up to 28 days before the treatment.

This involves visiting the clinic so we can collect information, carry out tests and in some cases take samples.

Most participants will receive Modi-1 5 times within the first 6 months…then once every 3 months for approximately…2 years, or until your doctor decides the treatment is complete. Whichever comes first.

Follow up visits are scheduled at regular intervals…to collect information, take blood tests and carry out scans to monitor your cancer.

All medical information and any samples collected will be stored or disposed of, legally and securely.

By taking part in this study you are helping doctors learn more about how to treat cancer.

For more information... Send us an email or contact your nearest participating hospital.

Details can be found on our website.

Modi-1 Patient Information Tools

The Modi-1 Patient Information Tools provide more information about what will happen if you decide to take part in the study. There are 3 different sets of information so it is important that you choose the one that matches your treatment - if in doubt please make sure you check with your healthcare practitioner.

Patients with advanced and unresectable (HPV Negative) Head and Neck cancer, Renal Cell cancer and Triple negative breast cancer to receive:

Modi-1 Only

Modi-1 + standard of care CPI
Patients with Head and Neck cancer who are scheduled to have their cancer surgically removed, randomised to receive either:

Modi-1 or Modi-1 + CPI prior to surgery

Status

Oncologists across the UK are recruiting patients to this clinical trial with Head and Neck Cancer, Renal Cell Cancer and Triple Negative Breast Cancer. If you are not currently receiving treatment or are starting treatment with a checkpoint inhibitor, for any one of these cancer types and are interested to learn more about the ModiFY study please inform your cancer doctor and/or the research team at the e-mail address: [email protected].