RecruitingPHASE1INTERVENTIONAL

FusionVAC22_01: Fusion Transcript-based Peptide Vaccine Combined with Immune Checkpoint Inhibition

This research trial, called FusionVAC22_01, is exploring a new combination treatment for a rare type of liver cancer called Fibrolamellar Hepatocellular Carcinoma (FL-HCC) and other cancers that have a specific genetic change called the DNAJB1-PRKACA fusion. The new treatment involves a special vaccine (Fusion-VAC-XS15), which helps your body's immune system recognise and fight cancer cells, combined with an existing immune checkpoint inhibitor drug called Atezolizumab (TecentriqTM), which helps your immune system work more effectively. Researchers want to find out how safe this combined treatment is, what side effects it might cause, how well it boosts the immune system, and if it can help shrink tumours. This is an early stage (Phase 1) trial, meaning it's one of the first times this combination is being tested in people.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

University Hospital Tuebingen

Enrolment target

Start

26 Sep 2023

Estimated completion

01 Jan 2027

Fibrolamellar Hepatocellular Carcinoma

What is this study about?

This study is a Phase 1 clinical trial, which means it's an early-stage study designed to carefully test a new treatment for the first time in people. The main goals are to make sure the treatment is safe, to understand any side effects, and to see how the body reacts to it. They're also looking for early signs of how well it works against the cancer.

The trial is focusing on a rare liver cancer called Fibrolamellar Hepatocellular Carcinoma (FL-HCC), or other cancers that have a specific genetic change called a 'DNAJB1-PRKACA fusion'. This fusion is like a unique identifier in some cancer cells. The treatment involves two parts: a vaccine called Fusion-VAC-XS15 and an existing cancer drug called Atezolizumab (also known as TecentriqTM). The vaccine is designed to teach your immune system to recognise and attack cancer cells that have this specific genetic change. Atezolizumab is an 'immune checkpoint inhibitor' which helps your immune system by removing the brakes that some cancer cells put on it, allowing your immune system to fight the cancer more effectively.

By combining these two treatments, researchers hope to give your immune system a strong boost to target and destroy cancer cells. This research is an important step in finding new ways to treat these particular types of cancer. If this early phase shows promising results, it could lead to further studies in the future.

Key takeaways

This is an early-stage study (Phase 1) for a new combination cancer treatment.
It's for people with rare liver cancer (FL-HCC) or other cancers with a specific genetic change.
The treatment involves a special vaccine and an existing immune drug.
The main goals are to check safety, side effects, and early signs of how well it works.
Your cancer must have a specific genetic marker (DNAJB1-PRKACA fusion) to qualify.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of Fibrolamellar Hepatocellular Carcinoma (FL-HCC) or another type of cancer that has a specific genetic change called the DNAJB1-PRKACA fusion. This genetic change would need to be found through a special test of your cancer cells.

If you have a different type of cancer (not FL-HCC) with this genetic change, you might be able to join if your current cancer treatment isn't working, or if there are no other standard treatments available, or if you can't have or don't want standard treatments. Your general health should also be good enough for you to take part, meaning you can mostly look after yourself. Your doctors will also check that your organs, like your kidneys and liver, are working well enough and that you don't have certain infections like active Hepatitis B or C, or HIV.

It's very important that you understand what the study involves and are happy to sign a consent form. If you are able to have children, you and your partner would also need to agree to use effective contraception during and for some months after the study.

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 of age or older?
Have you been diagnosed with Fibrolamellar Hepatocellular Carcinoma (FL-HCC) or another cancer with a specific genetic change (DNAJB1-PRKACA fusion)?
Are you generally able to look after yourself and manage daily activities?
Are your kidney and liver functions within suitable ranges (your doctor can check this)?
Are you able and willing to use effective contraception if you or your partner could become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll receive the new vaccine (Fusion-VAC-XS15) and the cancer drug (Atezolizumab). The researchers will explain exactly how often you'll receive these and for how long. You'll have regular hospital visits for assessments, which will include blood tests to check your organ function, how your body is reacting to the treatment, and to look for specific immune responses. You will also have scans to see how your cancer is responding to the treatment. The total duration of your participation in the study, including treatments and follow-up, will be clearly explained by the study team.

Potential risks and benefits

Being part of a clinical trial means you're helping to advance medical knowledge, and you might be among the first to benefit from a new treatment. However, as this is an early-stage trial, the full benefits and potential side effects of this new combination treatment are not yet completely known. Like all medicines, the treatments could cause side effects. The medical team will closely monitor you and explain any potential risks. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University Hospital Tuebingen
Verified postcode
Tübingen, Germany· Recruiting

Common questions

What is Fibrolamellar Hepatocellular Carcinoma?

It's a rare type of liver cancer that tends to affect younger people. This study is specifically looking for people with this cancer or other cancers with a particular genetic change.

What is a 'fusion gene'?

A fusion gene happens when two different genes accidentally join together. In this study, they're looking for a specific one called DNAJB1-PRKACA in cancer cells, which acts like a target for the new treatment.

What does a 'Phase 1' trial mean?

Phase 1 means it's one of the first times this combination treatment is being tested in people. The main goals are to make sure it's safe and to see what side effects might happen.

What is the difference between the vaccine and the cancer drug?

The vaccine (Fusion-VAC-XS15) is designed to teach your immune system to specifically attack the cancer cells with the special genetic change. The drug (Atezolizumab) helps your immune system work more effectively overall to fight cancer.

Will I get 'placebo' treatment?

No, in this study, everyone taking part will receive the active new vaccine (Fusion-VAC-XS15) and the immune checkpoint inhibitor drug (Atezolizumab). There is no placebo group.

How to find out more

Juliane Walz, Prof. Dr.

kketi@med.uni-tuebingen.de +49(0)707129 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.