NCT07619898Toborzás még nem indult2. fázis
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)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jún. 2.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 112 (tervezett)
- Első benyújtás
- 2026. máj. 19.
- Kezdés
- 2026. júl.
- Elsődleges befejezés
- 2028. dec.
- Fő szponzor
- Therakos LLC
- Betegségek
- Melanóma
- NCT-szám
- NCT07619898
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 112
- 2026. júl. és az elsődleges befejezés (2028. dec.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- 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.
Más betegség
- 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
Egyéb
- Participant has a diagnosis of uveal melanoma as the sole melanoma subtype
- Participants unable to tolerate the fluid shift associated with the ECP procedure.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.