Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT05915351
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-16
First Post:
2023-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enfortumab Vedotin in Previously Treated Locally Advanced or Metastatic Pancreatic Cancer (EPIC)
Sponsor:
University of Kansas Medical Center
Organization:
Study Overview
Official Title:
A Phase II Open-Label Study of Enfortumab Vedotin in Patients With Previously Treated Locally Advanced, Recurrent, or Metastatic Pancreatic Adenocarcinoma (EPIC)
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase II Open-Label Study of Enfortumab Vedotin in Patients with Previously Treated Locally Advanced, Recurrent, or Metastatic Pancreatic Adenocarcinoma (EPIC)
Detailed Description:
Enfortumab vedotin is an antibody-drug conjugate that delivers the microtubule-disrupting agent monomethyl auristatin E (MMAE) to cells expressing Nectin-4. Enfortumab vedotin is FDA approved for bladder cancer.
This is a phase II, open-label, study to evaluate the efficacy, safety and tolerability of Enfortumab vedotin in participants with previously treated locally advanced, recurrent, or metastatic pancreatic adenocarcinoma
This is a phase II, open-label, study to evaluate the efficacy, safety and tolerability of Enfortumab vedotin in participants with previously treated locally advanced, recurrent, or metastatic pancreatic adenocarcinoma
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: