Not recruiting

Study on Calcium Chloride Hexahydrate, Irreversible Electroporation, and Pembrolizumab for Patients with Metastatic Colorectal Cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a treatment for patients with metastatic colorectal cancer, which is a type of cancer that starts in the colon or rectum and has spread to other parts of the body. The study involves a combination of treatments, including calcium electroporation and irreversible electroporation, followed by an immunotherapy drug called pembrolizumab, also known by its code name MK-3475. Calcium electroporation is a technique that uses electrical pulses to introduce calcium into cancer cells, while irreversible electroporation uses electrical pulses to destroy cancer cells. Pembrolizumab is a medication that helps the immune system fight cancer cells.

The purpose of this study is to determine how effective and safe this combination of treatments is for patients with this type of cancer. Participants in the study will receive the treatments over a period of time, with the maximum treatment period being 12 months. The study will involve regular monitoring and assessments to evaluate the response to the treatment and any side effects that may occur. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

Throughout the study, various methods will be used to assess the treatment's impact, including biopsies, which are small samples of tissue taken from the body, and imaging techniques like ultrasound. The study aims to gather information on how the treatment affects the cancer, the overall survival of participants, and their quality of life. The results will help determine if this combination of treatments could be a beneficial option for patients with metastatic colorectal cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participants will be required to provide a signed informed consent. This document confirms understanding of the study and agreement to participate.
Participants must meet specific health criteria, including adequate bone marrow, kidney, liver, and coagulation function. These will be assessed through blood tests and other medical evaluations.
Step 2
Initial assessments
Participants will undergo a series of initial assessments to confirm eligibility. This includes confirming the presence of stage IV, non-resectable pMMR colorectal cancer and ensuring the primary tumor is reachable for treatment.
A minimum of two metastatic tumors must be present, with one suitable for a procedure called irreversible electroporation (IRE).
Step 3
Treatment phase
The treatment phase involves a combination of procedures and medications. Participants will receive calcium electroporation (Ca-EP) and irreversible electroporation (IRE).
Following these procedures, participants will be administered pembrolizumab, a medication given through an intravenous infusion. The dosage is 25 mg/mL, and the frequency and duration will be determined by the study protocol.
Step 4
Ongoing monitoring
Participants will be monitored regularly to evaluate the safety and tolerability of the treatment. This includes regular check-ups and tests to assess the body's response.
Biopsies may be taken from a metastasis not treated with IRE to evaluate the systemic response.
Step 5
Evaluation of outcomes
The study will evaluate various outcomes, including tumor response and overall survival. This will involve imaging tests and other assessments.
Participants will also complete quality of life questionnaires to provide feedback on their experience during the study.

Who can join the trial?

14 criteria

Must have signed an informed consent form.
Must be at least 18 years old.
Must have a confirmed diagnosis of stage IV, non-resectable pMMR colorectal cancer. This means the cancer is advanced and cannot be removed by surgery.
The main cancer must be located on the left side of the colon or in the rectum.
The main tumor must be reachable during a procedure called endoscopy.
Must have at least two metastatic tumors. One tumor must be suitable for a procedure called IRE, and another tumor must be available for a biopsy.
Must have previously received chemotherapy or have a specific type of disease that has not progressed for a certain period.
Must have a life expectancy of more than 3 months.
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means being fully active or having some symptoms but being able to carry out light work.
Must have adequate bone marrow function, which includes having enough red blood cells, white blood cells, and platelets.
Must have adequate kidney function, meaning the kidneys are working well enough.
Must have adequate liver function, meaning the liver is working well enough.
Must have adequate coagulation function, meaning the blood can clot properly.
Must follow specific conditions regarding fertility, pregnancy, or breastfeeding. This includes using contraception and not being pregnant or breastfeeding.

Who cannot join the trial?

3 criteria

Patients who do not have colorectal cancer cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

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Verified sites

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Verified
Zealand University Hospital
Koege, Denmark

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Investigated drugs

Calcium Electroporation
is a treatment that uses electrical pulses to help calcium enter cancer cells. The idea is that the extra calcium can damage the cancer cells and help to kill them. This treatment is being tested to see if it can work well with other therapies to fight cancer.
Irreversible Electroporation
is a technique that uses electrical pulses to create tiny holes in cancer cells. These holes can cause the cells to die. This method is being studied to see if it can help destroy cancer cells more effectively when used with other treatments.
Pembrolizumab
is a type of immunotherapy that helps the body's immune system fight cancer. It works by blocking a protein called PD-1, which can stop the immune system from attacking cancer cells. By blocking this protein, pembrolizumab can help the immune system recognize and destroy cancer cells more effectively.

What is already known about the treatment

Calcium electroporation
This treatment involves injecting calcium directly into the tumor and then applying electrical pulses to the area. It is currently being studied in clinical trials for its effectiveness and safety in treating colorectal cancer. The main goal is to see if it can help destroy cancer cells when used with other treatments like irreversible electroporation and immunotherapy. At the molecular level, calcium electroporation works by increasing calcium levels inside cancer cells, which can lead to cell death. It is classified as a type of local cancer treatment.
Pembrolizumab
This medication is given as an infusion into a vein, usually in a hospital or clinic setting. It is an approved treatment for various cancers and is being studied in combination with other therapies for colorectal cancer. Pembrolizumab works by helping the immune system recognize and attack cancer cells. It blocks a protein called PD-1, which can prevent the immune system from attacking cancer cells. This medication is classified as an immune checkpoint inhibitor.

Investigated diseases

Colorectal cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It typically starts as small, benign clumps of cells called polyps that can develop into cancer over time. As the disease progresses, cancer cells can invade and destroy normal tissue, potentially spreading to other parts of the body. The progression of colorectal cancer can lead to symptoms such as changes in bowel habits, blood in the stool, and abdominal discomfort. The disease can advance through various stages, from localized growths to widespread metastasis. Understanding the progression is crucial for managing the disease effectively.