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

NCT07619898 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2026-06-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

methoxsalen

Sterile solution used in conjunction with CELLEX ECP

DEVICE

Extracorporeal photopheresis (ECP)

Methoxsalen is used in conjunction with the CELLEX ECP

DRUG

Vedolizumab

Vedolizumab will be administered intravenously

DRUG

Infliximab

Infliximab will be administered intravenously

DRUG

Mycophenolate Mofetil (MMF)

Mycophenolate Mofetil will be administered orally or intravenously

DRUG

Azathioprine

Azathioprine will be administered orally or intravenously

Sponsors & Collaborators

  • Therakos LLC

    lead INDUSTRY

Principal Investigators

  • Isabelle T Seemann, Ph.D · Therakos LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-12-31
Completion
2029-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07619898 on ClinicalTrials.gov