Overview

EPIC- Extracorporeal Photopheresis (ECP) for Immune-related Colitis

Status:
SUSPENDED
Trial end date:
2027-02-19
Target enrollment:
Participant gender:
Summary
The photoactivating agent UVADEX (methoxsalen) is used in conjunction with extracorporeal photopheresis (ECP) as an immunomodulatory therapy approved for the treatment of cutaneous T-cell lymphoma. ECP involves collecting whole blood from the patient, separating white blood cells (WBCs) via centrifugation, combining them with UVADEX, and then exposing them to ultraviolet A (UVA) light. All blood components, including the treated WBCs, are then returned to the patient. Immune Checkpoint inhibitor (ICI) therapy is used to treat different types of cancer, and one major side-effect of ICI therapy is immune-related colitis (ir-colitis). The main purpose of the study is to evaluate the efficacy of UVADEX in conjunction with ECP versus best available therapy (BAT) in participants with melanoma or NSCLC that suffer from ir-colitis with inadequate response to steroids.
Phase:
PHASE2
Details
Lead Sponsor:
Therakos LLC
Treatments:
Infliximab
Methoxsalen
vedolizumab