Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

Safety and efficacy of IMM-101 combined with stereotactic radiotherapy in patients with limited metastatic pancreatic cancer (MEPANC-1)

This research study, called MEPANC-1, is for people with pancreatic cancer that has spread to a few other places. The study is split into two parts. First, it will check how safe a new drug called IMM-101 is when given alongside a powerful type of radiation therapy called SBRT. They will be looking for any side effects. Once they know it's safe, the second part of the study will see how effective this combined treatment is at fighting the cancer. This means they will check if it helps control the cancer's growth, how long people live, and how it affects their daily lives, including their comfort and well-being. This study aims to find new and better ways to treat this type of cancer.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

100

Start

13 Aug 2024

Limited metastatic pancreatic cancer

What is this study about?

This study, known as MEPANC-1, is exploring a new way to treat pancreatic cancer that has spread a little to other parts of the body. When cancer spreads, doctors call it "metastatic." This study focuses on people where the spread is "limited," meaning it hasn't gone everywhere.

The treatment being tested combines a special medicine called IMM-101 with a powerful and very focused type of radiation, known as Stereotactic Body Radiotherapy (SBRT). SBRT is designed to hit cancer cells very precisely while trying to spare healthy tissue. IMM-101 is a new type of treatment that aims to get the body's own immune system to fight the cancer.

The study has two main goals. First, the researchers need to make sure that giving IMM-101 together with SBRT is safe and doesn't cause too many problems or side effects. This is very important when trying new treatments. Once they have a good understanding of its safety, the second goal is to see how well this combined treatment works in controlling the cancer. They will check if it stops the cancer from growing, helps people live longer, and improves their quality of life. They will also look at how the treatment affects the body's immune cells and certain markers in the blood related to cancer.

Key takeaways

This study combines a new medicine (IMM-101) with focused radiation (SBRT).
It's for pancreatic cancer that has spread a little (limited metastatic).
The study has two parts: checking safety first, then how well it works.
It also looks at your quality of life and immune system changes.
It's open to adults aged 18 and older.

Who may be eligible?

This study is for adults generally aged 18 and over who have been diagnosed with pancreatic cancer that has spread, but only to a limited number of spots in their body. Both men and women are welcome to take part in this research.

To be considered, you would need to have specific types of limited metastatic pancreatic cancer, and your general health would be checked to make sure you can safely take part in the study. Your cancer doctor will be able to tell you if your specific situation fits what the researchers are looking for.

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?
Do you have pancreatic cancer?
Has your pancreatic cancer spread, but only to a limited number of spots?
Are you generally well enough to take part in a clinical trial?
Are you willing to have IMM-101 and SBRT treatment?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve getting the new medicine IMM-101 and specific radiation treatment called SBRT. You would also have regular check-ups, which include blood tests before, during, and after treatment to monitor your immune system and certain cancer markers. Your quality of life will also be assessed regularly using questionnaires to understand how the treatment might affect your daily well-being. You would also have scans to see how the cancer is responding to the treatment. This will help doctors understand how well the treatment is working. The study also measures how long you live after starting different treatments.

Potential risks and benefits

Potential benefits of participating in this study include receiving a new and potentially effective treatment approach for your cancer that isn't widely available yet. This treatment might help control your cancer and potentially improve your quality of life. However, there are also potential risks, as new treatments can have unexpected side effects or might not work for everyone. These side effects could range from mild to serious, and the research team will carefully monitor you. You will be fully informed of all known risks before joining. Remember, taking part in any clinical trial is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future 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
Netherlands

Common questions

What is 'limited metastatic pancreatic cancer'?

It means pancreatic cancer that has spread, but only to a few specific areas in your body, not widely throughout.

What is IMM-101?

IMM-101 is a new medicine being tested. It's designed to help your body's immune system fight the cancer cells.

What is SBRT?

SBRT stands for Stereotactic Body Radiotherapy. It's a very precise type of radiation treatment that targets cancer cells with high doses while trying to protect healthy tissue.

Will I know if the treatment is working?

Yes, doctors will use scans and blood tests regularly to see how your cancer is responding to the treatment.

Can I leave the study if I want to?

Yes, you can choose to leave the study at any time, for any reason, and it will not affect your medical care.