CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
6MHP +3 moredrug
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/NCT04364230
NCT04364230Phase 2Completed

Enhanced Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists in Patients With Melanoma

Craig L Slingluff, Jr·interventional·Posted Apr 28, 2020·Updated Jul 16, 2024

In Brief

A Phase 2 clinical trial evaluating 6MHP, NeoAg-mBRAF, and 2 other interventions for Melanoma and 2 related conditions. Completed, enrolled 22 participants across 2 sites.

Detailed Summary

This study evaluates whether it is safe to administer a peptide vaccine made of 6MHP and a mutated neoantigen peptide (BRAF585-614-V600E) combined with adjuvants. The adjuvants that will be used in this trial are a CD40 antibody (CDX-1140) and a toll-like receptor (TLR) 3 agonist (Poly-ICLC). The study will also investigate the effects of the vaccine and the adjuvants on the immune response. The investigators will monitor these effects by performing tests in the laboratory on participants' blood and skin tissue.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedApr 28, 2020
Enrollment StartSep 28, 2020
Primary CompletionMar 14, 2024
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 6.2 years ago

Interventions

6MHPdrug

6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides

NeoAg-mBRAFdrug

BRAF 586-614 (V600E) peptide to which a histidine has been added to the N-terminus, resulting in BRAF 585-614 (V600E).

PolyICLCdrug

polyICLC, local adjuvant

CDX-1140drug

CDX-1140, local adjuvant