NCT07619898Not yet recruitingPhase 2
PHOENIX-ECP- Extracorporeal Photopheresis for Immune-related Colitis and/or Hepatitis in Advanced Melanoma With Inadequate Response to Steroid Exposure
PHOENIX- 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 or Hepatitis With Inadequate Response to Corticosteroids in Participants With Unresectable or Metastatic Melanoma Treated With Immune Checkpoint Inhibitors (ICI)
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 112 (estimated)
- First submitted
- 19 May 2026
- Start date
- Jul 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Therakos LLC
- Diseases
- Melanoma
- NCT number
- NCT07619898
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 112
- From Jul 2026 to the primary completion date, Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
- 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.
Other illness
- 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.
- Treatment of ir-colitis or ir-hepatitis with any systemic therapy other than corticosteroids
- Pre-existing liver disease
- Active alcohol use disorder
- Contraindications or known allergic reaction to any of study intervention and/or procedures
Other
- Participant has a diagnosis of uveal melanoma as the sole melanoma subtype
- Participants unable to tolerate the fluid shift associated with the ECP procedure.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.