NCT05609656

Electroporation and Immunotherapy in Metastatic Colorectal Cancer

Calcium Electroporation in Combination With Irreversible Electroporation and Immunotherapy in Patients With Proficient Mismatch Repair System (pMMR) Metastatic Colorectal Cancer - A Prospective, Phase 2 Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Ismail Gögenur · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The investigators hypothesize that Ca-EP targeting the primary CRC tumor combined with IRE targeting a metastasis will be a promising, safe two target approach to ensure sufficient immune response both locally and systemic to potentiate the efficacy of immunotherapy in patients with pMMR metastatic CRC.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DEVICE	Irreversible electroporation	Percutaneous ablation of a metastatic lesion. Irreversible electroporation is delivered through the NanoKnife system (AngioDynamics, New York, USA). The system is CE approved for medical use.
DEVICE	Calcium electroporation	Just before the reversible electroporation, calcium chloride will be injected into the primary tumor. The electroporation will be delivered as at least four pulses and up to eight pulses. The device is repositioned after each pulse to ensure coverage of the entire surface area of the tumor. The reversible electroporation regime will be delivered through the endoscopic device EndoVE®, while the ePORE® will be used for pulse generation, both CE approved.
DRUG	Pembrolizumab	Pembrolizumab 200 mg as an IV infusion every 3 weeks (+/- 3 days) for up to 12 months Pembrolizumab is an immune checkpoint inhibitor (PD-1-inhibitor).

Timeline

• Start date: 2023-01-26
• Primary completion: 2024-04-08
• Completion: 2024-05-02
• First posted: 2022-11-08
• Last updated: 2024-06-03

Locations

1 site across 1 country: Denmark