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A Comparison of Matured Dendritic Cells and Montanide® in Study Subjects With High Risk of Melanoma Recurrence

Melanoma Clinical Trial

Official title:
Poly-ICLC Matured DC as an Adjuvant for NY-ESO-1 and Melan-A/MART-1 Peptide Vaccination Compared to Montanide® ISA-51 VG, in Study Subjects With Melanoma in Complete Clinical Remission But at High Risk of Disease Recurrence

Clinical Trial Summary

Vaccine adjuvants are compounds used to increase specific immune responses to antigens, but have minimal toxicity or lasting immune effects on their own. This study investigates the use of dendritic cells as an adjuvant for NY-ESO-1 and Melan-A/MART-1 peptides compared to Montanide® in study subjects with melanoma in complete clinical remission.

Clinical Trial Description

This is a Phase II open label, randomized two-arm study to evaluate the safety, tolerability, and immunogenicity of Poly-ICLC matured DCs as an adjuvant for NY-ESO-1 and Melan-A/MART-1 peptides (ARM A; DC Vaccine) compared to Montanide® ISA-51 VG (ARM B; Montanide Vaccine), both with systemic administration of Poly-ICLC on days 1 and 2 in study subjects with melanoma in complete clinical remission but at high-risk for disease recurrence. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02334735
Study type Interventional
Source Icahn School of Medicine at Mount Sinai
Contact
Status Completed
Phase Phase 2
Start date July 1, 2015
Completion date July 15, 2020
View Details
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