Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2025-12-28 @ 4:57 AM
Study NCT ID:
NCT01176461
Status:
COMPLETED
Last Update Posted:
2023-01-18
First Post:
2010-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multiple Class I Peptides & Montanide ISA 51 VG w Escalating Doses of Anti-PD-1 ab BMS936558
Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Organization:
Study Overview
Official Title:
A Pilot Trial of a Vaccine Combining Multiple Class I Peptides and Montanide ISA 51 VG With Escalating Doses of Anti-PD-1 Antibody BMS-936558 for Patients With Unresectable Stages III/IV Melanoma
Status:
COMPLETED
Status Verified Date:
2023-01
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 pilot phase 1, open-label, single center, multi-dose, dose-escalation study of BMS-936558 in combination with or without a peptide vaccine.
The purpose of this study is to test the side effects of an investigational vaccine with an immune booster. Investigators also wish to find out its effects on the patient's immune system and whether it will shrink their melanoma.
The purpose of this study is to test the side effects of an investigational vaccine with an immune booster. Investigators also wish to find out its effects on the patient's immune system and whether it will shrink their melanoma.
Detailed Description:
BMS-936558 will be administered as an i.v. infusion, using a volumetric pump with a 0.2 micron in-line filter at the protocol-specified dose(s) and rate.
The vaccine consists of the following peptides: gp100280-288 (288V), and NY-ESO-1157-165 (165V).
NOTE: \*Patients in cohorts 1-5 will receive the peptide vaccine, but not those in cohort 6.
Blood samples are collected for pharmacokinetic and immunologic analysis.
After completion of study therapy, patients are followed up periodically for 2 years.
The vaccine consists of the following peptides: gp100280-288 (288V), and NY-ESO-1157-165 (165V).
NOTE: \*Patients in cohorts 1-5 will receive the peptide vaccine, but not those in cohort 6.
Blood samples are collected for pharmacokinetic and immunologic analysis.
After completion of study therapy, patients are followed up periodically for 2 years.
Study Oversight
Has Oversight DMC:
False
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?: