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Vaccination With 6MHP, With or Without Systemic CDX-1127, in Patients With Stage II-IV Melanoma

NCT03617328 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2024-02-06

No results posted yet for this study

Summary

This study evaluates whether it is safe to administer a peptide vaccine (6MHP) with adjuvants and the CDX-1127 monoclonal antibody, and whether the adjuvants and the CDX-1127 monoclonal antibody boost immune responses to the vaccine. In this study, the adjuvants are Montanide ISA-51 and polyICLC. The investigators will monitor these effects by performing tests in the laboratory on participants' blood and tissue from a vaccine site.

Conditions

Interventions

BIOLOGICAL

6MHP

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

DRUG

Montanide ISA-51

Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant

DRUG

polyICLC

polyICLC, local adjuvant

DRUG

CDX-1127

CDX-1127, anti-CD27 monoclonal antibody

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
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-13
Primary Completion
2024-01-19
Completion
2024-01-19
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 NCT03617328 on ClinicalTrials.gov