The ModiFY Study

The ModiFY Study is a first-in-human clinical trial in patients with head and neck cancer, renal cancer, and triple negative breast cancer

The ModiFY study: Overview

The ModiFY clinical trial, is being conducted in hospitals across the UK, so that researchers can assess whether the Modi-1 vaccine when given to patients with specific cancer types:

Is safe at different doses
Can trigger the immune system to fight cancer
Is effective at shrinking tumours

The clinical trial is recruiting patients with the following advanced cancer types:

(HPV negative) Head and Neck Cancer
Renal Cell Cancer
Triple Negative Breast Cancer

The study is also recruiting patients with Head and Neck Cancer that are planning to undergo surgery.

The short video below provides more information about the 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.

Objectives

Researchers across the UK aim to address the following questions in the ModiFY clinical trial:

Is Modi-1 vaccination safe at different doses?
Are any side effects related to Modi-1 tolerable?
How strongly does Modi-1 trigger the immune system to fight cancer?
How effective is Modi-1 in shrinking tumours?

Patients will be treated with Modi-1 vaccine on its own (monotherapy), and in combination with a checkpoint inhibitor (CPI) such as pembrolizumab or nivolumab (where these are standard of care).

How does the Modi-1 vaccine work?

This short video explains how the Modi-1 vaccine works.

Modi-1: How does the Modi-1 vaccine work?

Modi-1 is a vaccine that may help treat your cancer by boosting your immune system to shrink your tumour.

Modi-1 contains three peptides, these peptides are also known as antigens. An antigen can be any substance that triggers an immune response in your body.

The Modi-1 antigens are small parts of a protein designed to help your immune system fight cancer.

One important group of cells in the immune system are the antigen presenting cells or APCs.

When we inject you with Modi-1, the three antigens are taken up by APCs in your blood. The APCs display the three Modi-1 antigens on its cell surface.

Another important group of cells in the immune system are the T cells. T cells are white blood cells, otherwise also known as lymphocytes.

When a T cell sees an APC with the Modi-1 antigens on its surface, it recognises it. This signal causes the T cell to become ‘activated’.

Cancer cells can also have the antigens on their surface that look like the three Modi-1 antigens.

When activated T cells see these cancer cells, they can then attack and destroy them.

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].