Clinical Trial

PHOENIX-ECP- Extracorporeal Photopheresis for Immune-related Colitis and/or Hepatitis in Advanced Melanoma With Inadequate Response to Steroid Exposure

Study acronym: PHOENIX-ECP
Not Yet Recruiting Phase 2
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Summary
Extracorporeal photopheresis (ECP) is an immunomodulatory therapy in which the photoactivating agent methoxsalen (also known as UVADEX) is used in combination with ultraviolet A (UVA) light. Immune checkpoint inhibitor therapy is widely used for the treatment of several cancers, including melanoma. However, a common immune-related adverse event associated with this therapy is Immune-related colitis or hepatitis. Corticosteroids are typically the first-line treatment for this condition, but some participants do not respond adequately. The purpose of this study is to evaluate the efficacy of ECP in the treatment of immune-related (ir)-colitis and ir-hepatitis with inadequate response to corticosteroids, and to compare its efficacy to other second-line immunosuppressant therapies. The ECP procedure in this study is performed using the CELLEX® device, a fully closed-loop extracorporeal blood circulation device. The CELLEX device is used in conjunction with methoxsalen.
Trial Details
NCT Number NCT07619898
Lead Sponsor Therakos LLC
Conditions Colitis, Hepatitis, Melanoma (Skin Cancer)
Enrollment 112 participants
Start Date 2026-07
Primary Completion 2028-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-02