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Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma (Including Ocular Melanoma)

NCT04364230 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-07-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

6MHP

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

DRUG

NeoAg-mBRAF

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

DRUG

PolyICLC

polyICLC, local adjuvant

DRUG

CDX-1140

CDX-1140, local adjuvant

Sponsors & Collaborators

  • Celldex Therapeutics

    collaborator INDUSTRY

  • Craig L Slingluff, Jr

    lead OTHER

Principal Investigators

  • Craig L. Slingluff, Jr., MD · University of Virginia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-28
Primary Completion
2024-03-14
Completion
2024-03-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04364230 on ClinicalTrials.gov