PHOENIX-ECP: A Phase 2, Randomized, Controlled, Open-label, Multicenter Study to Evaluate the Efficacy and Safety/Tolerability of Extracorporeal Photopheresis (ECP) Versus Best Available Therapy (BAT) for the Treatment of Immune-related Colitis and/or Hepatitis with Inadequate Response to Corticosteroids in Participants with Unresectable or Metastatic Melanoma Treated with Immune Checkpoint Inhibitors
Sponsor: Therakos Europe Limited
Phase: 2
Disease: Unresectable melanoma, Metastatic melanoma, Immune checkpoint inhibitor-induced colitis, Immune checkpoint inhibitor-induced hepatitis
EU trial number: 2026-526261-14-00
Population: Adults with unresectable or metastatic melanoma previously treated with an immune checkpoint inhibitor, with Grade 2 or higher immune-related colitis and/or hepatitis that is corticosteroid-refractory or corticosteroid-dependent. Participants must have paused or discontinued immune checkpoint inhibitor therapy and have ECOG performance status 0-2.
Register Investigator Interest
Interested in offering this trial to suitable patients?