CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
DEC-205/NY-ESO-1 Fusion Protein CDX-1401 +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02129075
NCT02129075Phase 2Completed

A Phase II, Open-Label, Multicenter, Randomized Study of CDX-1401, a Dendritic Cell Targeting NY-ESO-1 Vaccine, in Patients With Malignant Melanoma Pre-Treated With Recombinant CDX-301, a Recombinant Human Flt3 Ligand

National Cancer Institute (NCI)·interventional·Posted May 2, 2014·Updated Nov 16, 2021

In Brief

A Phase 2 clinical trial evaluating DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and 1 other intervention for Cutaneous Melanoma and 11 related conditions. Completed, enrolled 60 participants across 7 sites.

Detailed Summary

This phase II trial studies the effect of a vaccine called CDX-1401 given with or without a biologic drug called CDX-301 in treating patients with stage IIB-IV melanoma. The cancer vaccine CDX-1401 attaches to a protein that is made in tumor cells. The vaccine helps the body recognize the tumor to fight the cancer. The biologic drug CDX-301 may help the body make more of the tumor fighting cells, known as dendritic cells. Another biologic drug, poly-ICLC, may stimulate the immune system and help these dendritic cells mature so that they can recognize the tumor. Giving CDX-301 may make the immune response to a combination of CDX-1401 and poly-ICLC better.

Study Details

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 2, 2014
Enrollment StartApr 9, 2014
Primary CompletionMar 28, 2016
Study CompletionMay 18, 2018
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 12.2 years ago

Interventions

DEC-205/NY-ESO-1 Fusion Protein CDX-1401biological

Given SC or ID

Poly ICLCdrug

Given SC

Recombinant Flt3 Ligandbiological

Given SC