Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

An open label, phase 1 study to evaluate the safety, feasibility and immunogenicity of an allogeneic, cell-based vaccine (VIDIDENCEL) in high grade serous ovarian cancer patients after primary treatment (ALISON)

This study is for women who have been diagnosed with an aggressive type of ovarian cancer, called high-grade serous ovarian cancer, and have already finished their main treatments like surgery and chemotherapy. The study is called ALISON and it's looking at a new treatment called VIDIDENCEL. VIDIDENCEL is a vaccine made from special cells. This is the first time this vaccine will be given to people, so it's a very early-stage study (Phase 1). The main goals are to find out if the vaccine is safe, if it's possible to give it to patients, and if it helps their immune system recognize and fight the cancer cells. It's hoped that this new vaccine could eventually help prevent the cancer from returning.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Universitair Medisch Centrum Groningen

Enrolment target

Start

16 Sep 2024

High grade serous ovarian cancer

What is this study about?

This study, called ALISON, is designed for women who have a specific type of ovarian cancer, known as high-grade serous ovarian cancer. This is an aggressive form of ovarian cancer. The study is for patients who have already completed their initial treatments, which usually include surgery and chemotherapy. The main idea behind this study is to test a new kind of treatment called VIDIDENCEL. This isn't a typical medicine; it's a vaccine that uses special cells to try and train your body's immune system to fight any remaining cancer cells, or to prevent the cancer from coming back.

Because this is the very first time VIDIDENCEL is being given to people, it's called a 'Phase 1' study. At this early stage, the most important thing for the researchers is to check if the vaccine is safe for patients. They also want to make sure it's practical to give to people, and to see if the body's immune system reacts to it in a positive way. Your immune system is your body's natural defense against illness, and the hope is that this vaccine can boost it to recognize and attack cancer cells.

Even though it's an early-stage study, the hope is that new treatments like VIDIDENCEL could one day offer better ways to manage ovarian cancer and improve the chances of long-term health for women affected by it. By taking part, you would be helping doctors learn more about this promising new approach.

Key takeaways

This study is for women with a specific aggressive type of ovarian cancer.
It's testing a brand new cell-based vaccine called VIDIDENCEL after standard treatments.
The main aim is to see if the vaccine is safe and how the body reacts to it (Phase 1 study).
It's open to women aged 18 and over, who have completed their initial cancer treatments.
Taking part means helping to develop future treatments for ovarian cancer.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would need to be a woman, aged 18 or older. There is no upper age limit, meaning older women can also be considered.

Crucially, you would need to have been diagnosed with high-grade serous ovarian cancer. You must also have finished your primary treatments for this cancer, such as surgery and chemotherapy, and your doctors would confirm that your cancer is currently stable or in remission.

There will be other detailed medical checks to make sure this study is safe and suitable for you specifically. These checks may include reviewing your past medical history, current health, and any other medications you are taking. Your doctor will be able to discuss all the specific requirements 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 a woman?
Are you 18 years old or older?
Have you been diagnosed with high-grade serous ovarian cancer?
Have you completed your main treatments (like surgery and chemotherapy) for your ovarian cancer?
Is your cancer currently controlled or in remission after your primary treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new vaccine, VIDIDENCEL. As this is a Phase 1 study, the main focus is on safety, so doctors will closely monitor you to see how your body reacts to the vaccine. This will involve several visits to the hospital or clinic at regular times to have check-ups, blood tests, and possibly other scans or tests. These appointments allow the research team to see if the vaccine is safe and if your immune system is responding as hoped. We don't have exact details on the number or length of visits from the trial description, but these would be fully explained by the study team. You would also have regular discussions with the study doctors and nurses about how you are feeling. The total duration of your involvement could range from several months to a year or more, depending on the study's design and follow-up plan.

Potential risks and benefits

Taking part in a study like this means you might be among the first to receive a new treatment, which could potentially benefit you or future patients. However, because it's a new vaccine, the potential benefits are not certain, and there might be side effects or risks that doctors don't fully know about yet. These can range from mild (like feeling tired or having a sore arm) to more serious ones. You would be carefully monitored for any problems. Remember, your participation is completely 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.

—
Unverified
Netherlands

Common questions

What exactly is an 'allogeneic, cell-based vaccine'?

It's a type of vaccine made from special cells that are grown in a lab, not directly from your own body. The idea is to teach your immune system to recognise and fight cancer cells.

What does 'Phase 1' mean for a clinical trial?

Phase 1 is the very first stage where a new treatment is given to people. The main goals are to check if it's safe to use and to find the right dose, rather than to see how well it works against the cancer yet.

Will I still receive my standard treatments if I join this study?

This study is for women who have already completed their main treatments. The vaccine is given after these standard treatments, so it won't replace them.

What is 'high-grade serous ovarian cancer'?

It's a common and often aggressive type of ovarian cancer. Researchers hope this vaccine can help prevent it from returning after initial treatments.

How long would I be involved in the study?

The exact duration isn't specified in the summary, but Phase 1 studies often involve regular monitoring over several months to a year or more to assess safety and immune responses. The study team will give you a clear timeline.