Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-26 @ 10:00 AM
Study NCT ID:
NCT01672450
Status:
COMPLETED
Last Update Posted:
2015-07-08
First Post:
2012-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Intratumoral Injection of Interleukin-2 and Ipilimumab in Patients With Unresectable Stages III-IV Melanoma
Sponsor:
University of Utah
Organization:
Study Overview
Official Title:
A Phase I Study of Intratumoral Injection of Interleukin-2 and Ipilimumab in Patients With Unresectable Stages III-IV Melanoma
Status:
COMPLETED
Status Verified Date:
2015-07
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:
This is a single center, open phase I dose escalation study. This study will assess the highest tolerable intratumoral dose of ipilimumab (Yervoy) in combination with IL-2 (Proleukin) in patients with unresectable stages III-IV melanoma with accessible cutaneous, subcutaneous, and/or nodal lesions. The objective is to primarily assess the safety of the drug combination, and to secondarily obtain preliminary data on the clinical efficacy of the combination.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: