Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2026-01-22 @ 8:20 AM
Study NCT ID:
NCT02425306
Status:
TERMINATED
Last Update Posted:
2023-10-30
First Post:
2015-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma
Sponsor:
Craig L Slingluff, Jr
Organization:
Study Overview
Official Title:
A Trial to Evaluate the Immunogenicity and Safety of a Melanoma Helper Peptide Vaccine Plus Novel Adjuvant Combinations (MEL63)
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual to part 2 of the study. Accrual to part 1 is complete.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mel63; CHAMP
Brief Summary:
This study evaluates whether it is safe to administer a peptide vaccine in combination with different adjuvants. Adjuvants are substances that may boost immune responses vaccines. In this study, the adjuvants are Montanide ISA-51, polyICLC and cyclophosphamide. This study will also evaluate the effects of the combination of the peptide vaccine and the adjuvants on the immune system. The investigators will monitor these effects by performing tests in the laboratory on participants' blood, a lymph node, and tissue from the sites of vaccination.
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?: