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)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.