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

27. maj 2026 opdateret af: Therakos LLC

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)

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

112

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. 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.
  2. Participants diagnosed with ir-colitis and/or ir-hepatitis with a severity of Grade 2 or higher, based on ASCO Guidelines (
  3. Participants with endoscopic evidence of ir-colitis
  4. Participants with inadequate response to corticosteroids, as defined per protocol
  5. Participants who have Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.

Exclusion Criteria:

  1. 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.
  2. Participant has a diagnosis of uveal melanoma as the sole melanoma subtype
  3. Treatment of ir-colitis or ir-hepatitis with any systemic therapy other than corticosteroids
  4. 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.
  5. Pre-existing liver disease
  6. Active alcohol use disorder
  7. Concomitant treatment with any chemotherapy or targeted therapy for the treatment of unresectable or metastatic melanoma.
  8. Use of any investigational agent within 5 half-lives of the investigational agent prior to randomization.
  9. Contraindications or known allergic reaction to any of study intervention and/or procedures
  10. Participants unable to tolerate the fluid shift associated with the ECP procedure.
  11. Positive result for active or previous viral infections: covid-19, hepatitis B/C, CMV, EBV, adenovirus
  12. History of previous or concurrent malignancies within the last 3 years, other than unresectable or metastatic melanoma.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Methoxsalen in Conjunction with Extracorporeal Photopheresis System (ECP)
Participants will receive methoxsalen, in conjunction with ECP
Medicin: methoxsalen
Sterile solution used in conjunction with CELLEX ECP
Andre navne:
  • UVADEX
Enhed: Extracorporeal photopheresis (ECP)
Methoxsalen is used in conjunction with the CELLEX ECP
Andre navne:
  • CELLEX
Aktiv komparator: Best Available Therapy (BAT)
Participants with ir-colitis will receive either Infliximab or Vedolizumab as per the investigator's choice. Participants with ir-hepatitis will receive Mycophenolate Mofetil (MMF) or Azathioprine as per the investigator's choice.
Medicin: Vedolizumab
Vedolizumab will be administered intravenously
Medicin: Infliximab
Infliximab will be administered intravenously
Medicin: Mycophenolate Mofetil (MMF)
Mycophenolate Mofetil will be administered orally or intravenously
Medicin: Azathioprine
Azathioprine will be administered orally or intravenously

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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)
Tidsramme: Week 12
Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Duration of irAE response
Tidsramme: Week 64
Time from the start of irAE response to either the relapse of irAE (if relapse occurs), or a censoring event.
Week 64
Progression Free Survival (PFS) for Melanoma
Tidsramme: Week 64
Week 64
Overall Survival (OS)
Tidsramme: Week 64
Week 64
Proportion of Participants With at Least Stable Disease as Assessed by RECIST 1.1 at Week 12 and During Follow-up
Tidsramme: Week 12 and Week 64
Week 12 and Week 64
Proportion of Participants with Treatment-Emergent Adverse Event (TEAEs) per Common Toxicity Criteria for Adverse Events (CTCAE) v5.0
Tidsramme: From first dose of the study drug up to end of study (up to Week 64)
From first dose of the study drug up to end of study (up to Week 64)
Cumulative Systemic Corticosteroid Exposure From Randomization to Week 12
Tidsramme: Up to Week 12
Up to Week 12
Peak Dose of Systemic Corticosteroid Exposure From Randomization to Week 12
Tidsramme: Up to Week 12
Up to Week 12
Proportion of Participants who Completely Discontinue Systemic Corticosteroid Treatment Until Week 12
Tidsramme: Week 12
Week 12
Time to Complete Discontinuation of Systemic Corticosteroids for at Least 1 Week
Tidsramme: From screening up to the first documentation of the discontinuation of systemic corticosteroid (up to Week 64)
From screening up to the first documentation of the discontinuation of systemic corticosteroid (up to Week 64)
Time to First Response of Randomized irAE Based on ASCO Criteria
Tidsramme: Week 64
Week 64
Proportion of Participants With at Least one irAE who Achieve Response (as Defined per ASCO Criteria) at Week 12
Tidsramme: Week 12
Week 12
Proportion of Participants With at Least One irAE That Resolves Completely (as per CTCAE v5.0) and Remains Resolved Until Week 12
Tidsramme: Week 12
Week 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Therakos LLC

Efterforskere

  • Studieleder: Isabelle T Seemann, Ph.D, Therakos LLC

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. december 2028

Studieafslutning (Anslået)

1. december 2029

Datoer for studieregistrering

Først indsendt

19. maj 2026

Først indsendt, der opfyldte QC-kriterier

27. maj 2026

Først opslået (Faktiske)

2. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TKS2001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Ja

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Ingen

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