AuthorisedTherapeutic exploratory (Phase II)Interventional

MITO CERV4: Single arm phase II study on Pembrolizumab in pre neoplastic high grade HPV-related vulvar and cervical lesions

This study is investigating a new way to treat women who have abnormal changes in their cervix or vulva due to the HPV virus. These changes, known as pre-cancerous lesions, are not yet cancer but could become cancer if left untreated. The study is a Phase II trial, meaning it's still in the earlier stages of testing. Participants will receive a medicine called Keytruda (pembrolizumab). The main goal is to see if these pre-cancerous changes disappear after treatment, before surgery. Researchers also want to understand if the treatment reduces the amount of HPV and to check for any side effects.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrolment target

Start

12 Nov 2024

Patients with pre neoplastic high grade HPV-related vulvar and cervical lesions

What is this study about?

This study is called MITO CERV4 and it's looking into a new treatment for certain changes in women's bodies. Specifically, it's for women who have abnormal cells in their cervix or vulva that are caused by the Human Papillomavirus (HPV). These abnormal cells are often called 'high-grade lesions' and are considered 'pre-cancerous,' meaning they could, over time, develop into cancer if not treated.

The treatment being tested is a medicine called Keytruda (its active ingredient is Pembrolizumab). This medication is given as a liquid that drips slowly into your vein. Doctors want to see if Keytruda can help these pre-cancerous conditions go away, or become less severe, before surgery is performed. This is important because finding new ways to treat these conditions could potentially help reduce the need for extensive surgery or prevent cancer from developing.

The main thing doctors will measure is whether these abnormal cells in the cervix have disappeared when they look at tissue samples taken during surgery. They will also look at whether similar changes in the vulva have gone away, how safe the medicine is by tracking any side effects, and if the HPV virus itself can no longer be detected. They will also check to make sure these precancerous changes don't get worse and turn into cancer.

Key takeaways

This study is testing a new medicine for pre-cancerous changes in the cervix and vulva caused by HPV.
The medicine is called Keytruda and is given as a drip.
The main aim is to see if the medicine can make these changes disappear before surgery.
Researchers will also check for side effects and if HPV is still present.
It's for women aged 18 and over with specific high-grade pre-cancerous lesions.
Participation involves regular hospital visits, treatments, and follow-up.

Who may be eligible?

This study is for women who are 18 years old or older. There is no upper age limit, meaning women of any adult age can potentially take part.

To be eligible, you must have been diagnosed with high-grade pre-cancerous changes in your cervix or vulva that are linked to the HPV virus. These are conditions that, if not treated, have a higher chance of turning into cancer.

There will also be other specific health checks and tests that the study doctors will need to do to make sure the study is safe for you. These might include blood tests and a review of your general health and medical history, as certain health conditions or medications might prevent you from joining.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman?
Are you 18 years old or older?
Have you been told you have high-grade pre-cancerous changes in your cervix or vulva?
Are these changes linked to the HPV virus?
Are you generally well enough to take part in a study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medication, Keytruda, which is given as a drip into your vein. You will have regular hospital visits for these treatments and to have check-ups. These check-ups will involve doctors asking about your health and any side effects, as well as blood tests and examinations. Researchers will closely monitor your pre-cancerous lesions to see if they are improving or disappearing.

At a certain point, you will have surgery to remove the abnormal cells. Tissue samples from this surgery will be checked to see if the medicine has worked. You will also have follow-up appointments after your treatment and surgery to continue monitoring your health, check for any long-term effects, and see if the HPV virus is still present. The total duration of your participation, including follow-up, will be explained by the study team.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new medicine that might help treat your pre-cancerous condition before surgery, and potentially reducing the extent of surgery needed. However, there's no guarantee the treatment will work for everyone, or that it will work better than standard treatments. There are also potential risks, as Keytruda can cause side effects, which doctors will discuss with you. These side effects can range from mild to serious, and the study team will closely monitor you for any issues. It's important to remember that participating in a clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is HPV?

HPV stands for Human Papillomavirus, a common virus that can cause certain abnormal cell changes and, in some cases, lead to cancer.

What are 'pre-cancerous lesions'?

These are abnormal changes in cells that are not yet cancer, but doctors believe they could develop into cancer over time if not treated.

What is Keytruda?

Keytruda is a medicine that works with your body's immune system to fight certain diseases. In this study, we're seeing if it can help tackle abnormal cells.

Will I still need surgery?

Yes, even if the medicine helps, surgery is part of the study plan to remove the abnormal cells and check the results of the treatment.

Is this medicine available to everyone?

No, Keytruda is being studied for this condition in a clinical trial. It's not yet a standard approved treatment for pre-cancerous cervical or vulvar lesions.