Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2025-12-24 @ 12:16 PM
NCT ID:
NCT01176461
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.
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.
Study:
NCT01176461
Study Brief:
Protocol Section:
NCT01176461