Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Activity and safety of peptide-based immunotherapy in an umbrella window of opportunity phase II study in patients with squamous cell carcinoma of the head and neck.

This study, called a 'Phase II' trial, is exploring new ways to treat cancer in the head and neck. Specifically, it's for a type called squamous cell carcinoma. Researchers are testing different combinations of two experimental vaccines, named IO102 and IO103, along with a substance called Montanide. The main goal is to see if these treatments can get the body's immune system to recognise and fight cancer cells more effectively. They're also carefully watching for any side effects and how patients' tumours respond. This trial aims to gather important information about how well these new treatments work and if they are safe for people with this type of cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Cliniques Universitaires Saint-Luc

Enrolment target

Start

18 Sep 2024

squamous cell carcinoma of the head and neck

What is this study about?

This study is looking into new treatments for squamous cell carcinoma, which is a type of cancer that can develop in the head and neck area. The treatments being tested are special vaccines, called IO102 and IO103, which are designed to boost your body's natural defences (your immune system) to fight the cancer. The idea is that these vaccines might help your immune system recognise and attack cancer cells.

In this trial, different groups of patients will receive either vaccine IO103, vaccine IO102, or a combination of both, along with a helper substance called Montanide. This is a 'Phase II' study, which means the researchers are mainly focused on understanding how well these new treatments work against the cancer and making sure they are safe for people. They will be carefully monitoring how your immune system responds, how the cancer changes, and any side effects you might experience.

The information gathered from this study will help doctors learn more about these potential new treatments. It will help them understand if these vaccines can effectively get your immune system to target cancer and if they could be good options for future cancer care. We hope this research will lead to better ways to help people living with head and neck cancer.

Key takeaways

This study is testing new vaccine treatments for head and neck cancer.
It aims to boost your immune system to fight cancer cells.
Researchers are carefully checking for safety and how well the treatment works.
You must be 18 years or older to participate.
Participation involves regular check-ups and scans.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

More specific details about your health and your cancer will determine if this study is right for you. Your medical team will carefully review your situation to see if you meet all the requirements. This ensures the study is safe and appropriate for everyone involved.

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 18 years old or older?
Do you have squamous cell carcinoma of the head and neck?
Are you able to attend regular hospital visits?
Are you willing to undergo blood tests and scans?
Have you discussed your current health with your doctor regarding study participation?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive one of the experimental vaccines (IO103, IO102, or both) along with Montanide. You will have regular appointments for check-ups, where doctors will assess your health, monitor any side effects, and perform blood tests. They will also use scans like MRI to see how your tumour is responding to the treatment.

The researchers will be looking closely at how your immune system reacts to the vaccines, by testing your blood. The exact number of visits and the total length of time you'll be involved will depend on the specific treatment plan and how you respond, but your care team will explain everything thoroughly before you start.

Potential risks and benefits

Taking part in a study like this might offer the chance to receive a new treatment that isn't widely available yet, which could potentially help your condition. However, there's no guarantee the treatment will be effective, and you might experience side effects, some of which could be serious. All potential side effects will be fully explained to you. 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
Belgium

Common questions

What type of cancer is this study for?

This study is for a type of cancer in the head and neck called squamous cell carcinoma.

What are IO102 and IO103?

IO102 and IO103 are experimental vaccines designed to help your immune system fight cancer.

Will I definitely get the active treatment?

Yes, everyone in this study will receive one of the experimental vaccine combinations.

How long will the study last?

The total duration of your participation will depend on the treatment plan and how you respond, which your doctor will discuss with you.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time, and this will not affect your future medical care.