Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Calcium electroporation in combination with irreversible electroporation and immunotherapy in patients with pMMR metastatic colorectal cancer - A prospective, phase 2 study

This research study is investigating a new treatment approach for people with metastatic colorectal cancer, which is a type of bowel cancer that has spread. The study is combining a treatment called Calcium electroporation (Ca-EP) and irreversible electroporation (IRE) – these are methods that use electrical pulses to target cancer cells – with an immunotherapy drug called pembrolizumab (also known as KEYTRUDA). Immunotherapy helps your body's own immune system fight cancer. The main goal of this early-stage study is to check how safe this combination of treatments is and if people can tolerate it well. Researchers will also look at how effective it is in shrinking tumours and improving how long people live, as well as checking their quality of life.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Zealand University Hospital

Enrolment target

Start

07 Apr 2022

Colorectal cancer

What is this study about?

This study is exploring a new way to treat a type of bowel cancer that has spread to other parts of the body. This is called metastatic colorectal cancer. The treatment being tested is a combination of a few different approaches. Two of these are called Calcium electroporation (Ca-EP) and irreversible electroporation (IRE). These are special techniques where doctors use electrical pulses to treat cancer cells. This is combined with a well-known immunotherapy drug called pembrolizumab, which helps your body's immune system recognise and fight cancer.

The main aim of this study is to understand if this combination of electrical treatments and immunotherapy is safe for patients and if they can tolerate it without too many side effects. This is an early-stage study, so it's focused on safety first. The researchers will also be looking to see if the treatment helps to shrink tumours, how it affects the cancer spreading, and how it impacts a person's overall quality of life. They will use scans, blood tests, and questionnaires to gather this information.

Finding new and effective ways to treat metastatic colorectal cancer is very important. Studies like this help doctors learn more about promising new treatments and can pave the way for better care in the future. By combining different types of treatment, the hope is to find a more powerful way to fight the cancer.

Key takeaways

This study combines special electrical treatments with an immunotherapy drug (KEYTRUDA) for bowel cancer that has spread.
It's an early-stage study primarily focused on checking the safety and tolerability of this new combination.
Researchers will also look at how well the treatment shrinks tumours and affects quality of life.
Participation involves regular hospital visits, treatments, and health checks.
It's for adults (18+) with metastatic colorectal cancer, and both men and women can join.
Being part of the study could help develop new treatments for bowel cancer in the future.

Who may be eligible?

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

There will be other important health requirements that doctors will check to make sure the study is right and safe for you. These might include details about your specific type of bowel cancer, whether it has spread, and your general health. It's important that you meet certain medical criteria to ensure the treatment could be beneficial and that you can safely take part.

Only the study team can confirm if you are eligible after reviewing your medical history. They will fully explain all the 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 colorectal (bowel) cancer that has spread to other parts of your body?
Are you able to attend regular hospital appointments?
Are you generally able to undergo medical treatments and assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive a combination of treatments: infusions of KEYTRUDA, and special electrical treatments (calcium electroporation and irreversible electroporation). You will need to attend hospital appointments for these treatments and for regular check-ups. These check-ups will involve things like blood tests, scans, and possibly biopsies (taking small tissue samples) to see how the treatment is working and to monitor your health.

You will also be asked to complete questionnaires, such as the EORTC QLQ-C30, which help to assess your quality of life during the study. The total duration of your participation, including follow-up appointments, will depend on your individual response to treatment, but comprehensive follow-up is standard to track long-term outcomes and safety.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. You might benefit from a new treatment that isn't yet widely available, and your participation will help advance medical knowledge for others. However, like all medical treatments, this combination therapy may cause side effects, some of which could be serious or unexpected. The study team will monitor you closely for any side effects. 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 immunotherapy?

Immunotherapy is a type of cancer treatment that helps your body’s own immune system fight the cancer cells. KEYTRUDA (pembrolizumab) is an example of an immunotherapy drug used in this study.

What is electroporation?

Electroporation is a medical technique that uses electrical pulses. In this study, it's used alongside calcium to target and treat cancer cells.

Will this treatment cure my cancer?

This is a research study to see how safe and effective the new combination treatment is. While it aims to treat the cancer, it's not guaranteed to provide a cure. Doctors will monitor how the treatment works for you.

What does 'Phase 2 study' mean?

A Phase 2 study means the treatment has already been checked for basic safety. Now, researchers are looking more closely at its effectiveness and continued safety in a larger group of people with the condition.

Will I have to pay to be part of this study?

Typically, you will not have to pay for the study treatments or assessments when participating in a clinical trial. Any travel, parking, or other patient-related costs will be discussed by the study team.