Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase IIb, Open-label, Randomized Study of Nab-Paclitaxel and Gemcitabine plus/minus VCN-01 in Patients with Metastatic Pancreatic Cancer (VIRAGE)

This research is a Phase II study, meaning we're exploring if a new treatment called VCN-01 can help people with pancreatic cancer that has spread to other parts of the body. Participants will receive standard chemotherapy (Nab-Paclitaxel and Gemcitabine) with or without VCN-01. The main goals are to find out if VCN-01 helps people live longer and to check for any side effects it might cause. We'll also look at how long the cancer stays stable, if the tumours shrink, and changes in a specific blood marker. This is an important step in finding better treatments for this type of cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Theriva Biologics S.L.

Enrolment target

Start

02 Oct 2024

Metastatic Pancreatic Cancer

What is this study about?

This study is called VIRAGE and it's looking for new ways to treat pancreatic cancer that has spread, also known as metastatic pancreatic cancer. When cancer spreads, it means it has moved from where it started to other parts of the body. This study is testing a new treatment, called VCN-01, alongside the usual chemotherapy medicines (Nab-Paclitaxel and Gemcitabine) that patients already receive. Think of it like adding an extra ingredient to a recipe to see if it makes the final dish even better. The main aim is to see if adding VCN-01 helps people live longer and if it's safe to use.

This is a Phase II study, which means it's an important step after earlier safety tests. In this phase, researchers are trying to understand how effective the new treatment is and continue to monitor for any side effects. It’s open-label, meaning both the patient and their doctors will know whether they are receiving VCN-01 or not.

Beyond checking how long people live, the study will also look at other important things. This includes how long the cancer stays stable without growing, whether tumours shrink, and if a certain blood marker related to pancreatic cancer (called Ca 19.9) changes. These measurements help doctors understand the overall impact of the treatment. This research is vital because it helps us learn more about promising new treatments for serious conditions like metastatic pancreatic cancer.

Key takeaways

This study tests a new treatment (VCN-01) for advanced pancreatic cancer.
It combines VCN-01 with standard chemotherapy.
The main goals are to see if patients live longer and if VCN-01 is safe.
It's a Phase II study, actively exploring the new treatment's effects.
Participants can be men or women, aged 18 or older.

Who may be eligible?

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

However, these are just the basic requirements. There will be other medical checks and criteria that doctors will need to review to make sure the study is right and safe for you. For example, you would need to have been diagnosed with pancreatic cancer that has spread to other parts of your body. Your overall health and how well your body systems are working (like your liver and kidneys) will also be checked.

It’s important to talk to your doctor about your specific health situation to understand if you might be a good fit for this research. They can explain all the detailed requirements and answer any questions you have.

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 pancreatic cancer that has spread?
Are you comfortable with receiving either standard chemotherapy or standard chemotherapy plus a new drug?
Do you understand this study is investigating a new treatment?
Are you able to attend regular hospital or clinic visits for tests and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned by chance (like flipping a coin) to one of two groups. One group would receive the standard chemotherapy drugs plus the new VCN-01 treatment, while the other group would receive only the standard chemotherapy. Neither you nor your doctor would know which group you are in, if it were a blinded study, but this particular study is 'open-label', meaning you will know what treatment you are receiving.

You would have regular visits to the hospital or clinic. These visits would involve check-ups with the study doctors, blood tests, and scans to monitor your cancer and your general health. This is to make sure the treatment is working as expected and to keep a close eye on any side effects you might experience. The exact schedule of these visits and tests would be clearly explained by the study team.

The medication would be given by the hospital or clinic staff as per the study plan. The total duration of your participation would depend on how your treatment is progressing and how your body responds. Even after treatment stops, there may be follow-up appointments to track your long-term health. The study team will explain all the details, including how long each part is expected to last.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. A potential benefit is that you might receive a new treatment that could be more effective than existing options, or if you're in the control group, you'll still receive the standard of care. This is also an opportunity to contribute to medical knowledge that could help future patients. However, there are potential risks, including side effects from the new treatment that are not yet fully known, or from the standard chemotherapy. There's also no guarantee the new treatment will work for you. Close monitoring will be in place to manage any side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without affecting your current or future medical care.

Locations (1)

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

—
Unverified
Spain

Common questions

What is pancreatic cancer that has spread?

It means the cancer started in the pancreas and has moved to other parts of your body.

What are Nab-Paclitaxel and Gemcitabine?

These are common chemotherapy medicines used to treat pancreatic cancer.

What is VCN-01?

VCN-01 is a new treatment being tested in this study alongside standard chemotherapy.

Why is this called a 'Phase II' study?

Phase II studies explore how effective a new treatment is and continue to check for safety after initial tests.

Will I know if I'm getting the new treatment?

Yes, this is an 'open-label' study, so you and your doctors will know if you receive VCN-01.