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NCT Number: NCT07619898

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

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.

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Key information

Conditions

Colitis Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Hepatitis Intestinal Diseases Liver Diseases Melanoma Melanoma (Skin Cancer) Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Methoxsalen

Drug

Sterile solution used in conjunction with CELLEX ECP

Other names: UVADEX

Extracorporeal photopheresis (ECP)

Device

Methoxsalen is used in conjunction with the CELLEX ECP

Other names: CELLEX

Vedolizumab

Drug

Vedolizumab will be administered intravenously

Infliximab

Drug

Infliximab will be administered intravenously

Mycophenolate Mofetil (MMF)

Drug

Mycophenolate Mofetil will be administered orally or intravenously

azathioprine

Drug

Azathioprine will be administered orally or intravenously

Primary outcomes

  1. Proportion of Participants Who are in Steroid-free response at Week 12 for the Randomized Immune-related Adverse Event (irAE) (ir-colitis or ir-hepatitis)

    Time frame: Week 12

Secondary outcomes

  1. Duration of irAE response

    Time frame: Week 64

    Time from the start of irAE response to either the relapse of irAE (if relapse occurs), or a censoring event.

  2. Progression Free Survival (PFS) for Melanoma

    Time frame: Week 64

  3. Overall Survival (OS)

    Time frame: Week 64

  4. Proportion of Participants With at Least Stable Disease as Assessed by RECIST 1.1 at Week 12 and During Follow-up

    Time frame: Week 12 and Week 64

  5. Proportion of Participants with Treatment-Emergent Adverse Event (TEAEs) per Common Toxicity Criteria for Adverse Events (CTCAE) v5.0

    Time frame: From first dose of the study drug up to end of study (up to Week 64)

  6. Cumulative Systemic Corticosteroid Exposure From Randomization to Week 12

    Time frame: Up to Week 12

  7. Peak Dose of Systemic Corticosteroid Exposure From Randomization to Week 12

    Time frame: Up to Week 12

  8. Proportion of Participants who Completely Discontinue Systemic Corticosteroid Treatment Until Week 12

    Time frame: Week 12

  9. Time to Complete Discontinuation of Systemic Corticosteroids for at Least 1 Week

    Time frame: From screening up to the first documentation of the discontinuation of systemic corticosteroid (up to Week 64)

  10. Time to First Response of Randomized irAE Based on ASCO Criteria

    Time frame: Week 64

  11. Proportion of Participants With at Least one irAE who Achieve Response (as Defined per ASCO Criteria) at Week 12

    Time frame: Week 12

  12. Proportion of Participants With at Least One irAE That Resolves Completely (as per CTCAE v5.0) and Remains Resolved Until Week 12

    Time frame: Week 12

Study contacts

Contact information is provided by the study sponsor or research team.

Therakos TKS2001 Study Team

CONTACT

[email protected]

855-512-3327

Sponsors and collaborators

Lead sponsor

Therakos LLC

Industry

Registry information

Official study title

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)

Acronym: PHOENIX-ECP

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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