Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-29 @ 4:46 AM
Study NCT ID:
NCT03126461
Status:
WITHDRAWN
Last Update Posted:
2020-08-20
First Post:
2017-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SAbR Plus Ipilimumab Plus Nivolumab in Metastatic Melanoma Patients
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
Phase 2 Trial of SAbR Plus Ipilimumab Plus Nivolumab in Metastatic Melanoma Patients
Status:
WITHDRAWN
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
the project was never initiated and no participants were enrolled, it was closed permanently
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A one-arm, single center phase 2 trial of SAbR plus ipilimumab plus nivolumab in advanced metastatic melanoma patients
Detailed Description:
SAbR/GRID plus ipilimumab 3mg/kg IV q3wk x 4 plus nivolumab 1 mg/kg IV q3wk x 4, followed by nivolumab 240 mg IV q 2wk until progression or intolerable toxicity
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?:
False
Is an FDA AA801 Violation?: