Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

PANOVA-4: Pilot, Single arm Study of Tumor Treating Fields (TTFields, 150kHz) Concomitant with Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-Line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC)

The PANOVA-4 study is a Phase III clinical trial testing a new way to treat metastatic pancreatic ductal adenocarcinoma (mPDAC), which is a type of pancreatic cancer that has spread. This study is trying out a combination of therapies: a device that creates gentle electrical fields called Tumor Treating Fields (TTFields), along with three established medications: Atezolizumab (also known as Tecentriq), Gemcitabine, and Nab-Paclitaxel. The main goal is to see how well this combined treatment can stop the cancer from growing or even shrink it. They are also looking at how long people live with this treatment. This research aims to find more effective treatments for this challenging cancer, offering hope for better outcomes.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Novocure GmbH

Enrolment target

Start

16 Oct 2024

Metastatic pancreatic ductal adenocarcinoma (mPDAC)

What is this study about?

This clinical trial, known as PANOVA-4, is investigating a new treatment approach for a specific type of cancer called metastatic pancreatic ductal adenocarcinoma, or mPDAC. This is a form of pancreatic cancer that has spread to other parts of the body. The study is particularly important because pancreatic cancer can be very challenging to treat, and researchers are always looking for better options.

The treatment being tested is a combination of different therapies. One part involves something called Tumor Treating Fields, or TTFields. These are gentle electrical fields that are applied to the body, aiming to disrupt cancer cell division. This is combined with three existing medications: Atezolizumab (also known as Tecentriq), Gemcitabine, and Nab-Paclitaxel. These medications work in different ways to fight cancer, for example, by boosting the body's immune system or by directly interfering with cancer cell growth.

The main purpose of this study is to see how effective this combined treatment is at controlling the cancer. This means checking if the cancer stops growing, shrinks, or even disappears. The researchers will be closely monitoring patients to measure these effects. They also want to understand if this new combination helps people live longer. By combining these different treatments, the hope is to find a more powerful way to fight this advanced cancer.

Key takeaways

Tests a new combination treatment for advanced pancreatic cancer.
Combines gentle electrical fields (TTFields) with established cancer medications.
Aims to control cancer growth and improve survival.
Is a Phase III study, designed to confirm effectiveness.
Open to adults aged 18 and over, with metastatic pancreatic ductal adenocarcinoma, who are starting their first treatment for it.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or older. The study is open to both men and women.

The most important requirement is that you have been diagnosed with metastatic pancreatic ductal adenocarcinoma (mPDAC), which means your pancreatic cancer has spread to other parts of your body. This study is specifically for people who are receiving this combination of treatments as their very first treatment for mPDAC.

There might be other specific health conditions or medications that would prevent someone from joining, even if they meet these main criteria. A doctor involved in the study would go through all these details with you to see if the trial is a good fit.

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?
Have you been diagnosed with metastatic pancreatic ductal adenocarcinoma (mPDAC)?
Is this your first time receiving treatment for your mPDAC?
Are you comfortable with the idea of using a device that creates gentle electrical fields?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be receiving a combination of treatments. This includes using a device that creates gentle electrical fields (TTFields) along with regular infusions of three medications: Atezolizumab, Gemcitabine, and Nab-Paclitaxel. These treatments would be given according to a specific schedule decided by the study doctors.

You would have regular visits to the clinic for your treatments, as well as for various tests and check-ups. These would likely include blood tests, scans (like CT or MRI) to see how the cancer is responding, and physical examinations. These visits are important for the doctors to monitor your health and how well the treatment is working.

The total duration of your participation would depend on how your body responds to the treatment. You would continue receiving the study treatment for as long as it is helping you and you are tolerating it well. After stopping the treatment, you would still have follow-up appointments to track your health and long-term outcomes. The study staff will explain the full schedule and what to expect in detail.

Potential risks and benefits

Participating in a clinical trial can offer potential benefits, such as access to a new treatment combination that is not yet widely available, which might be more effective than standard options. However, there are also potential risks, as any medication or treatment can have side effects. The electrical fields, while gentle, may cause some skin irritation, and the medications can have their own set of side effects, which the study team would explain thoroughly. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (3)

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

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Unverified
Spain
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Unverified
Germany
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Unverified
Czechia

Common questions

What exactly are 'Tumor Treating Fields'?

Tumor Treating Fields (TTFields) are gentle electrical fields that are applied to the body using transducer arrays placed on the skin. They are designed to disrupt the growth of cancer cells without harming healthy cells as much.

What is 'metastatic pancreatic ductal adenocarcinoma'?

This is a type of pancreatic cancer that has spread from the pancreas to other parts of the body. 'Metastatic' means the cancer has spread.

Are the medications used in this study new?

Atezolizumab (Tecentriq), Gemcitabine, and Nab-Paclitaxel are existing cancer medications. The new aspect here is using them in combination with TTFields for pancreatic cancer.

What does a 'Phase III' study mean?

A Phase III study is a large study that compares a new treatment to standard treatments, or to placebo, to confirm if it's safe and more effective. It's a key step before a treatment can be approved.

What is the main goal of this study?

The main goal is to see how well this combined treatment can control the cancer (stop it from growing or shrink it) and also to see if it helps people live longer.