Electroporation and Immunotherapy in Metastatic Colorectal Cancer (NCT05609656) | Clinical Trial Compass
TerminatedPhase 2
Electroporation and Immunotherapy in Metastatic Colorectal Cancer
Stopped: The study was terminated on the basis on an evaluation of the efficacy and safety of the 4 included and treated patients.
Denmark4 participantsStarted 2023-01-26
Plain-language summary
The trial is designed as an investigator initiated prospective phase 2 study in patients with metastatic pMMR colorectal cancer (CRC) to determine the safety and efficacy of calcium electroporation (CaEP) performed concurrently with irreversible electroporation (IRE) followed by a PD-1 inhibitor (pembrolizumab).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Signed informed consent
✓. Age ≥ 18 years of age
✓. Histologically confirmed stage IV, non-resectable pMMR colorectal cancer
✓. The primary malignant tumor is left sided (cancer of the splenic flexure and cancer in regions distal to the splenic flexure, including the rectum)
✓. The primary tumor is described as reachable at index endoscopy
✓. At least two metastatic tumors must be present. One metastatic tumor, that in the opinion of the investigators is amenable to IRE, and at least one additional metastatic tumor that will not undergo IRE. Both lesions must be accessible for biopsy
✓. Previous chemotherapy a), or b):
✓. Patients refractory to, intolerable of, or refusing standard chemotherapy options including 5-FU, irinotecan, oxaliplatin, bevacizumab and EGFR-inhibitors e.g. panitumumab/cetuximab (if RAS/RAF wild type)
Exclusion criteria
✕. Prior treatment with an immune checkpoint inhibitor (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2 agent, or anti-CTLA-4 agent)
✕. Concurrent treatment with an investigational medicinal product
✕. Radiotherapy or major surgery within the last two weeks prior to entering the study
✕. Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results E.g
What they're measuring
1
The incidence rate of adverse events according to CTCAE v. 4.0