Ongoing Clinical Trials for Colorectal Cancer Stage IV
Currently, there are 3 clinical trials investigating new treatment approaches for Stage IV Colorectal Cancer. These studies are taking place across multiple European countries and are testing various combinations of immunotherapy, chemotherapy, and innovative techniques like electroporation. The trials focus on specific genetic characteristics of the cancer and aim to improve patient outcomes through novel treatment strategies.
Clinical trial locations
- Belgium
- Denmark
- Estonia
- France
- Germany
- Greece
- Hungary
- Italy
- Lithuania
- Netherlands
- Poland
- Romania
- Spain
Study Comparing MK-1308A and Pembrolizumab for Patients with Advanced Colorectal Cancer with High Microsatellite Instability or Mismatch Repair Deficiency
This trial focuses on patients who have a specific type of advanced colorectal cancer called Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR). These terms describe particular genetic changes in cancer cells that affect how the cancer grows and responds to treatment.
Main inclusion criteria:
- Confirmed diagnosis of Stage IV Colorectal Cancer
- Cancer must have the specific genetic features of MSI-H or dMMR
- Life expectancy of at least 3 months
- Cancer that can be measured by medical imaging
- Must provide a tumor tissue sample from a biopsy within the last 5 years or a new one
- Organs must be functioning adequately
- For one patient group: must have previously received standard treatments that either didn’t work or couldn’t be tolerated
- For another patient group: must have untreated Stage IV disease with no prior chemotherapy or immunotherapy
Main exclusion criteria:
- Patients without the specific MSI-H or dMMR genetic features cannot join this particular study
Focus of the trial: This study is testing several different immunotherapy combinations to see which works best at shrinking tumors and improving patient outcomes. Researchers want to find out how long treatment responses last, how long patients live without the cancer worsening, and overall survival rates. The trial will also carefully monitor safety and any side effects from the treatments.
Investigational drugs: The study is testing MK-1308A, which combines two medications called quavonlimab and pembrolizumab. It’s also testing pembrolizumab alone, as well as other combinations including MK-4280A, MK-7684A, and MK-4830 combined with pembrolizumab. These medications work by helping the body’s immune system recognize and attack cancer cells. All treatments are given through an intravenous infusion directly into a vein.
Study of Tisotumab Vedotin, Pembrolizumab, and Platinum Drug Combination for Patients with Advanced or Metastatic Solid Tumors
This trial is studying treatment options for patients with various types of advanced or metastatic solid tumors, including colorectal cancer. The cancer has either spread to nearby tissues or to other parts of the body.
Main inclusion criteria:
- Must have relapsed, locally advanced, or metastatic colorectal or pancreatic cancer, squamous non-small cell lung cancer, or squamous cell carcinoma of the head and neck
- Cancer has not responded to previous treatments and cannot be treated with standard therapy
- Cancer must be measurable according to specific medical guidelines
- Must be able to provide a tissue sample for testing, either recent or from within the last 2 years
- Must be an adult within the specified age range
Main exclusion criteria:
- Patients with cancer types other than solid tumors
- Patients who have not been diagnosed with locally advanced or metastatic disease
- Those outside the specified age range or unable to follow study procedures
Focus of the trial: The study aims to evaluate how well tisotumab vedotin works both alone and in combination with other treatments. Researchers will observe how tumors respond to treatment, how long responses last, and overall patient survival. The trial is divided into several parts, with some patients receiving tisotumab vedotin alone, while others receive it combined with pembrolizumab or with both pembrolizumab and platinum-based chemotherapy drugs like cisplatin or carboplatin.
Investigational drugs: Tisotumab vedotin is an antibody-drug conjugate that delivers a chemotherapy agent directly to cancer cells. Pembrolizumab is an immunotherapy that helps the immune system fight cancer. Platinum agents (cisplatin or carboplatin) are chemotherapy drugs that damage cancer cell DNA to stop their growth. All medications are administered through intravenous infusion.
Study on Calcium Chloride Hexahydrate, Irreversible Electroporation, and Pembrolizumab for Patients with Metastatic Colorectal Cancer
This trial is testing an innovative combination of treatments for patients with metastatic colorectal cancer, which means the cancer has spread from the colon or rectum to other parts of the body.
Main inclusion criteria:
- Must be at least 18 years old
- Confirmed diagnosis of stage IV, non-resectable pMMR colorectal cancer (cancer that cannot be removed by surgery)
- Main cancer must be located on the left side of the colon or in the rectum
- Main tumor must be reachable during endoscopy (a procedure using a flexible tube with a camera)
- Must have at least two metastatic tumors, with one suitable for a procedure called irreversible electroporation and another available for biopsy
- Must have previously received chemotherapy or have disease that has been stable for a certain period
- Life expectancy of more than 3 months
- Adequate bone marrow, kidney, liver, and blood clotting function
Main exclusion criteria:
- Patients without colorectal cancer
- Those outside the specified age range
- Members of vulnerable populations the study is not designed to include
Focus of the trial: This study is investigating whether a combination of calcium electroporation (using electrical pulses to introduce calcium into cancer cells), irreversible electroporation (using electrical pulses to destroy cancer cells), and pembrolizumab immunotherapy can effectively treat metastatic colorectal cancer. The trial will evaluate treatment effectiveness, safety, tumor response, overall survival, and quality of life. The maximum treatment period is 12 months, with regular monitoring throughout.
Investigational drugs: Calcium electroporation uses electrical pulses to help calcium enter cancer cells, which can damage and kill them. Irreversible electroporation uses electrical pulses to create tiny holes in cancer cells that cause them to die. Pembrolizumab is an immunotherapy drug that blocks a protein called PD-1, helping the immune system recognize and attack cancer cells more effectively. This medication is given as an intravenous infusion.
Summary
The three ongoing clinical trials for Stage IV Colorectal Cancer represent diverse approaches to treating this advanced disease. A notable observation is the widespread geographic availability of the first trial, which is being conducted across 13 European countries including Lithuania, Greece, Denmark, Romania, Belgium, Spain, Italy, Germany, Netherlands, Hungary, France, Poland, and Estonia. This broad reach may provide more opportunities for eligible patients to participate.
All three trials incorporate pembrolizumab, an immunotherapy medication, highlighting the importance of immune system-based treatments in current research for advanced colorectal cancer. The first trial specifically focuses on patients with MSI-H or dMMR genetic features and tests multiple immunotherapy combinations. The second trial takes a broader approach, including colorectal cancer among other solid tumors, and combines immunotherapy with chemotherapy. The third trial, conducted only in Denmark, represents the most innovative approach by combining traditional immunotherapy with novel electroporation techniques.
These studies offer different options depending on the specific characteristics of a patient’s cancer, previous treatments received, and geographic location. Patients interested in participating should discuss with their healthcare team whether they meet the criteria for any of these trials and what participation would involve.
