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

NCT06646016 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-12-26

No results posted yet for this study

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.

Conditions

  • Immune-related Colitis

Interventions

DRUG

Methoxsalen

Sterile solution used in conjunction with photopheresis procedure.

DRUG

Infliximab

Infliximab will be administered intravenously.

DRUG

Vedolizumab

Vedolizumab will be administered intravenously.

Sponsors & Collaborators

  • Therakos LLC

    lead INDUSTRY

Principal Investigators

  • Clinical Team Leader · Therakos LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-15
Primary Completion
2026-02-06
Completion
2027-02-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06646016 on ClinicalTrials.gov