PHOENIX-ECP- Extracorporeal Photopheresis for Immune-related Colitis and/or Hepatitis in Advanced Melanoma With Inadequate Response to Steroid Exposure
Starting soon · Phase 2
Conditions studied: Colitis, Hepatitis, Melanoma (Skin Cancer)
In brief
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.
Key facts
- Study ID
- NCT07619898
- Run by
- Therakos LLC
- People needed
- 112
- Starts
- 2026-07-01
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2026-06-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participants diagnosed with unresectable or metastatic melanoma ( Stage III and Stage IV) received ICI treatment (e.g., anti-PD-1, anti-PD-L1, anti-LAG-3, anti-CTLA-4 antibody, as ICI monotherapy or ICI combination therapy) and ICI paused or discontinued because of the development of ir-colitis or ir-hepatitis.
- Participants diagnosed with ir-colitis and/or ir-hepatitis with a severity of Grade 2 or higher, based on ASCO Guidelines (
- Participants with endoscopic evidence of ir-colitis
- Participants with inadequate response to corticosteroids, as defined per protocol
- Participants who have Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
You may not qualify if…
- Presence of irAEs in addition to and other than ir-colitis and/or ir-hepatitis, with a higher severity grade than the irAE for inclusion (ir-colitis/ir-hepatitis) based on ASCO guidelines.
- Participant has a diagnosis of uveal melanoma as the sole melanoma subtype
- Treatment of ir-colitis or ir-hepatitis with any systemic therapy other than corticosteroids
- Concurrent conditions which may require treatment with high dose corticosteroid (> 1 milligram per kilogram per day [mg/kg/day]) and interfere with the corticosteroid tapering schedule recommended by the protocol.
- Pre-existing liver disease
- Active alcohol use disorder
- Concomitant treatment with any chemotherapy or targeted therapy for the treatment of unresectable or metastatic melanoma.
- Use of any investigational agent within 5 half-lives of the investigational agent prior to randomization.
- Contraindications or known allergic reaction to any of study intervention and/or procedures
- Participants unable to tolerate the fluid shift associated with the ECP procedure.
- Positive result for active or previous viral infections: covid-19, hepatitis B/C, CMV, EBV, adenovirus
- History of previous or concurrent malignancies within the last 3 years, other than unresectable or metastatic melanoma.
Full record on ClinicalTrials.gov
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