Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06646016
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
EPIC- Extracorporeal Photopheresis ECP for Immune-related Colitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
EPIC - A Phase 2 Randomized Open-label Multicenter Controlled Study to Evaluate the Efficacy Safety and Tolerability of Extracorporeal Photopheresis ECP Versus Best Available Therapy BAT in Melanoma or Non-Small Cell Lung Cancer NSCLC Patients With Immune-related Colitis Induced by Immune Checkpoint Inhibitor Therapy Who Have Inadequate Response to Steroids
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPIC
Brief Summary:
The photoactivating agent UVADEX methoxsalen is used in conjunction with extracorporeal photopheresis ECP as an immunomodulatory therapy approved for the treatment of cutaneous T-cell lymphoma ECP involves collecting whole blood from the patient separating white blood cells WBCs via centrifugation combining them with UVADEX and then exposing them to ultraviolet A UVA light All blood components including the treated WBCs are then returned to the patient
Immune Checkpoint inhibitor ICI therapy is used to treat different types of cancer and one major side-effect of ICI therapy is immune-related colitis ir-colitis The main purpose of the study is to evaluate the efficacy of UVADEX in conjunction with ECP versus best available therapy BAT in participants with melanoma or NSCLC that suffer from ir-colitis with inadequate response to steroids
Immune Checkpoint inhibitor ICI therapy is used to treat different types of cancer and one major side-effect of ICI therapy is immune-related colitis ir-colitis The main purpose of the study is to evaluate the efficacy of UVADEX in conjunction with ECP versus best available therapy BAT in participants with melanoma or NSCLC that suffer from ir-colitis with inadequate response to steroids
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None