Ongoing Clinical Trials for Metastatic Colon Cancer
There are currently 2 clinical trials underway for metastatic colon cancer, exploring new immunotherapy approaches and combinations with chemotherapy. These trials are being conducted across several European countries including Belgium, France, Italy, and Spain.
Clinical trial locations
- Belgium
- France
- Italy
- Spain
Study Comparing Dostarlimab with CAPEOX and CAPEOX Alone for Patients with Untreated Stage III Colon Cancer
This trial is investigating whether adding an immunotherapy drug called dostarlimab to a standard chemotherapy combination called CAPEOX can improve outcomes for patients with Stage III colon cancer who have not yet received treatment. CAPEOX is a combination of two chemotherapy drugs: capecitabine, taken as tablets, and oxaliplatin, given through a vein.
Main inclusion criteria:
- Must be at least 18 years old
- Must have adenocarcinoma of the colon that has not been treated and can be removed by surgery
- The cancer must be classified as clinically T4N0 or Stage III
- The tumor must show specific characteristics indicating it is MMRp (has all four proteins: MLH1, MSH2, MSH6, PMS2) or has an MSS or MSI-L phenotype
- Must provide a fresh tumor tissue sample obtained during colonoscopy
- Must have an ECOG performance status of 0 or 1, meaning you can carry out normal or light activities
- Must have adequate organ function
- Must agree to use effective birth control if of childbearing potential
Main exclusion criteria:
- Having a different type of colon cancer than the one being studied
- Not being in the specific cancer stages being studied
- Not within the specified age range
- Being part of a vulnerable population requiring special protection
Focus and goals: The trial aims to determine whether adding dostarlimab to CAPEOX chemotherapy is more effective than CAPEOX alone. Dostarlimab works by helping the immune system recognize and attack cancer cells by blocking a protein called PD-1. Participants will be randomly assigned to receive either the combination treatment or chemotherapy alone, and will be monitored for up to 12 months to assess effectiveness and safety.
Investigational drugs: The main drug being tested is dostarlimab, an immune checkpoint inhibitor that helps the body’s immune system fight cancer. It is being studied in combination with CAPEOX, the standard chemotherapy combination of capecitabine and oxaliplatin.
Study on Botensilimab Alone and with Balstilimab or Drug Combination for Patients with Refractory Metastatic Colorectal Cancer
This trial is designed for patients with metastatic colorectal cancer that has spread to other parts of the body and has not responded to standard treatments. The study is testing a new immunotherapy drug called botensilimab, both alone and in combination with another immunotherapy called balstilimab, comparing these to standard care options.
Main inclusion criteria:
- Must have confirmed colorectal cancer that cannot be removed by surgery and has spread to other parts of the body
- Must have had at least one previous chemotherapy treatment for metastatic or recurrent disease
- Must be 18 years of age or older
- Must have a life expectancy of at least 12 weeks
- Must have an ECOG performance status of 0 or 1
- Must have adequate organ function confirmed by blood tests
- Must have measurable disease on imaging tests
- Must provide a recent tumor sample or be willing to provide a new biopsy
- Must have had tumor tested for MSI-H or dMMR genetic markers
- Must agree to use effective birth control if of childbearing potential
Main exclusion criteria:
- Having a different type of cancer than refractory metastatic colorectal cancer
- Not within the specified age range
- Unable to follow study procedures or instructions
- Having other serious health conditions that might interfere with the study
- Being pregnant or breastfeeding
- Recent participation in another clinical trial
- Allergies to the study medications
- Recent major surgery
- Active infection requiring treatment
- History of certain heart conditions
Focus and goals: The study will evaluate how well botensilimab works on its own and in combination with balstilimab compared to standard treatments like regorafenib or the combination of trifluridine and tipiracil. Both botensilimab and balstilimab are immunotherapy drugs that work by blocking proteins that help cancer cells hide from the immune system, thereby enhancing the body’s natural ability to fight cancer.
Investigational drugs: The main drugs being tested are botensilimab and balstilimab, both immunotherapy medications given as injections. These are being compared to standard treatments including regorafenib and the combination of trifluridine and tipiracil, which are taken as tablets.
Summary
These two clinical trials represent different approaches to treating colon cancer at different stages of the disease. The first trial focuses on earlier-stage disease in patients who have not yet received treatment, testing whether adding immunotherapy to standard chemotherapy can improve outcomes. The second trial targets more advanced disease that has not responded to previous treatments, exploring new immunotherapy combinations.
Both trials are being conducted across multiple European countries, with Belgium, Italy, and Spain participating in both studies, while France is involved only in the second trial. Both studies emphasize immunotherapy approaches, reflecting current research trends in cancer treatment that aim to harness the body’s immune system to fight cancer cells. Patients interested in participating should discuss with their healthcare team whether they meet the specific eligibility criteria for either trial.
