Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

Induction of neo-antigen specific T cells by specialized cross-presenting dendritic cells in epithelial ovarian cancer patients treated with neoadjuvant chemotherapy, the NEODOC study

This research study, called the NEODOC study, is looking into a new treatment approach for women with ovarian cancer, specifically epithelial ovarian cancer. The study focuses on using the patient's own immune system to fight the cancer more effectively. Researchers are investigating how special immune cells, known as 'dendritic cells', can be prepared in the lab to recognise and target cancer cells. These specially prepared cells are then given back to the patient after they've had their initial chemotherapy. The main goal is to see if this treatment can boost the patient's immune response against the cancer. This is an early-stage study, meaning it's one of the first times this specific treatment is being tested in humans, to make sure it's safe and to see if it has a positive effect on the immune system.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Stichting Radboud universitair medisch centrum

Enrolment target

Start

29 Nov 2024

Ovarian cancer

What is this study about?

The NEODOC study is all about helping your body's natural defences, your immune system, to fight ovarian cancer more powerfully. Imagine your immune system as an army that protects you from harm. Sometimes, cancer cells can hide from this army. This study aims to train a special type of 'commander' cell in your immune system, called a dendritic cell, to recognise and attack these hidden cancer cells.

Here's how it generally works: cancer cells have unique markers, like a barcode, that healthy cells don't. After you've had some initial chemotherapy, we can sometimes get a sample of your tumour. From this sample, we can take those unique cancer markers and use them to 'educate' your dendritic cells in the lab. These specially prepared dendritic cells are then given back to you. The hope is that these 'educated' cells will then lead your immune system's army to attack and destroy the cancer cells more effectively.

This is an early-stage study, meaning it's among the first times this treatment is being tested in people. The main goal is to see if this method can really boost your immune system's ability to fight the cancer. If it works well, it could become a new, gentle way to help treat ovarian cancer in the future, working alongside existing treatments like chemotherapy.

Key takeaways

This study explores an experimental immune treatment for ovarian cancer.
It aims to boost your own immune system to fight cancer more effectively.
The treatment involves preparing your own immune cells in the laboratory.
It's for women with epithelial ovarian cancer undergoing chemotherapy before surgery.
This is an early-stage study to check safety and initial effectiveness.
Participation is voluntary and won't affect your standard medical care.

Who may be eligible?

This study is open to adult women aged 18 and over, with no upper age limit, who have a specific type of ovarian cancer called epithelial ovarian cancer. You would also need to be undergoing chemotherapy treatment before having surgery for your cancer, often called neoadjuvant chemotherapy.

Before joining, a doctor would carefully check your medical history and current health to make sure this study is right for you and that taking part would be safe. They'll look at your overall health and make sure you meet all the specific criteria for the study.

It's important to remember that even if you meet these general criteria, there might be other reasons why you can't join the study, such as other medical conditions or specific test results. Your doctor will be able to discuss all of these details with you.

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?
Are you a woman receiving treatment for ovarian cancer?
Do you have 'epithelial' ovarian cancer?
Are you currently having chemotherapy *before* your surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a number of tests to check your current health and confirm you're suitable. Once you've started your initial chemotherapy for ovarian cancer, special immune cells would be taken from you, usually through a blood draw, to be prepared in the laboratory. You would then receive the specially prepared immune cells as an infusion, similar to how you receive chemotherapy, but less often. You'll have regular follow-up appointments with the study team. These appointments will involve blood tests to see how your immune system is responding and check your general health, as well as scans to monitor your cancer. These visits will continue for a certain period after your treatment part of the study finishes to make sure we gather all the important information about your health and treatment response. The total time you would be involved in the study, including follow-up, could be several months to a year or more, but the treatment itself is for a shorter, defined period.

Potential risks and benefits

Taking part in a research study like this offers the potential benefit of accessing a new treatment approach that isn't widely available yet, which might help your immune system fight your cancer more effectively. However, as with any new treatment, there are potential risks, including side effects from the treatment itself, which might be similar to mild flu symptoms, or from the procedures involved like blood draws. The study team will monitor you closely for any issues and will explain all known potential risks before you decide to join. It's very important to remember that joining a study is always your choice, and you are free 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.

—
Unverified
Netherlands

Common questions

What are 'dendritic cells'?

Dendritic cells are special cells in your body that are like the 'commanders' of your immune system. Their job is to show other immune cells what to attack, like cancer cells or infections.

What does 'neoadjuvant chemotherapy' mean?

This is chemotherapy given before surgery. It's often used to shrink the cancer first, making surgery easier or more effective.

Is this a new type of chemotherapy?

No, this isn't chemotherapy. It's an immunotherapy, which means it uses your body's own immune system to fight the cancer. It's given in addition to your regular chemotherapy.

Will I still have my surgery?

Yes, if you're taking part in this study, the plan is for you to continue with your standard treatment path, which typically includes surgery after your initial chemotherapy.

How long will I be involved in the study?

The active treatment part of the study usually lasts a few months, but you will have follow-up visits and monitoring for a longer period, potentially up to a year or more, to track your progress.