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.
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
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.
Parallel
methoxsalen
DrugSterile solution used in conjunction with CELLEX ECP
Extracorporeal photopheresis (ECP)
DeviceMethoxsalen is used in conjunction with the CELLEX ECP
Vedolizumab
DrugVedolizumab will be administered intravenously
Infliximab
DrugInfliximab will be administered intravenously
Mycophenolate Mofetil (MMF)
DrugMycophenolate Mofetil will be administered orally or intravenously
Azathioprine
DrugAzathioprine will be administered orally or intravenously
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)
Duration of irAE response
Time from the start of irAE response to either the relapse of irAE (if relapse occurs), or a censoring event.
Progression Free Survival (PFS) for Melanoma
Overall Survival (OS)
Proportion of Participants With at Least Stable Disease as Assessed by RECIST 1.1 at Week 12 and During Follow-up
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