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

Nivolumab With Ipilimumab Combined With TGFβ-15 Peptide Vaccine and Radiotherapy for Pancreatic Cancer (CheckVAC)

The CheckVAC study is for people who have advanced pancreatic cancer. Doctors are trying out a new combination of treatments: two existing anti-cancer drugs called nivolumab and ipilimumab, along with an experimental vaccine (TGFβ-15 peptide vaccine) and radiotherapy. This is a very early stage of research, sometimes called a Phase I study. The main goal is to check how safe this new treatment combination is, how it affects the body, and if it could potentially help patients. It's a first step in understanding if this novel approach might lead to better ways to treat advanced pancreatic cancer in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Region Hovedstaden

Enrolment target

Start

13 Sep 2024

advanced pancreatic cancer

What is this study about?

This study, known as CheckVAC, is looking into new ways to treat advanced pancreatic cancer. Pancreatic cancer can be very challenging to treat, so doctors are always searching for new and more effective options. This particular study is combining several different approaches. Firstly, it uses two established anti-cancer medications called nivolumab and ipilimumab. These drugs are a type of immunotherapy, which means they work by helping your body's own immune system fight cancer.

Secondly, the study is adding an experimental vaccine called TGFβ-15 peptide vaccine. Vaccines usually help prevent diseases, but in this case, it's designed to work alongside the other treatments to specifically target cancer cells. Finally, the treatment combination also includes radiotherapy, which uses high-energy rays to kill cancer cells and shrink tumours. The idea is that using all these treatments together might be more effective than using them alone.

Because this is a very early-stage study (Phase I), the main aim is to carefully check if this new combination of treatments is safe for people. Doctors will also be looking at how the treatments are absorbed, distributed, and processed by the body. This helps them understand the right dosages and makes sure the treatment doesn't cause too many unwanted side effects. If this early study shows promise, it could pave the way for larger studies in the future to see how well it works against the cancer itself.

Key takeaways

This is an early-stage study (Phase I) for advanced pancreatic cancer.
It combines two immunotherapy drugs, an experimental vaccine, and radiotherapy.
The main goal is to check the safety of this new treatment combination.
Open to adults aged 18 and over, both men and women.
Participation involves regular hospital visits for treatments and health checks.
You have the right to leave the study at any time.

Who may be eligible?

To be considered for the CheckVAC study, you would need to be an adult, meaning you are at least 18 years old. The study is open to both men and women.

The main condition for joining is that you have advanced pancreatic cancer. "Advanced" means the cancer has grown or spread beyond its original location. The study's medical team will need to check your full medical history and current health to make sure this study is right and safe for you.

There might be other health conditions or previous treatments that could mean you can't join the study. These details are important for your safety and to make sure the study results are clear. Your doctor or the study team would discuss all these requirements with you in detail.

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?
Do you have advanced pancreatic cancer?
Are you able to travel for regular hospital appointments?
Are you willing and able to follow the study's treatment and visit schedule?
Have you discussed this study with your main cancer doctor?

Answer every question to see your result.

What does participation involve?

Joining this study would involve several steps. You would first have screening appointments to check if you're a good fit. If you qualify, you would receive the study treatments, which include infusions of nivolumab and ipilimumab, doses of the TGFβ-15 peptide vaccine, and radiotherapy. The exact schedule for these will be carefully explained to you.

Throughout the study, you would have regular hospital visits. During these visits, doctors and nurses would perform various checks. These might include blood tests, physical examinations, and scans to monitor your health, how the treatment is affecting you, and how the cancer is responding. Some visits might involve detailed questionnaires or assessments about how you're feeling.

The total length of your participation would depend on several factors, including how you respond to the treatment and the study's design. After the main treatment period, there will likely be a follow-up phase where you continue to have check-ups, though less frequently, to monitor your long-term health and any effects from the treatment. All appointments and the total duration would be explained by the study team.

Potential risks and benefits

Participating in any clinical study comes with potential benefits and risks. A potential benefit of this study is that you might receive a new combination of anti-cancer treatments that could be more effective than standard options, especially as it's an advanced cancer study. You would also receive very close medical attention and monitoring. However, there are potential risks, primarily side effects from the medications, vaccine, and radiotherapy. These side effects can vary greatly and might include fatigue, nausea, skin reactions, or more serious issues, which the study team will discuss thoroughly. It's crucial to remember that 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.

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Unverified
Denmark

Common questions

What is advanced pancreatic cancer?

Advanced pancreatic cancer means the cancer has spread from where it started or cannot be completely removed by surgery.

What is a Phase I study?

A Phase I study is the first step where a new treatment is given to people. Its main goal is to check safety and find the right dose, rather than primarily testing how effective it is.

What are nivolumab and ipilimumab?

These are types of immunotherapy drugs. They work by helping your body's immune system fight cancer cells more effectively.

What is the TGFβ-15 peptide vaccine?

This is an experimental vaccine being tested in the study. It's designed to specifically target certain aspects of cancer cells, working alongside the other treatments.

Will I get radiotherapy?

Yes, if you join this study, the treatment plan includes radiotherapy in addition to the medications and the vaccine.