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Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma

NCT02425306 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-10-30

Study results available
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Summary

This study evaluates whether it is safe to administer a peptide vaccine in combination with different adjuvants. Adjuvants are substances that may boost immune responses vaccines. In this study, the adjuvants are Montanide ISA-51, polyICLC and cyclophosphamide. This study will also evaluate the effects of the combination of the peptide vaccine and the adjuvants on the immune system. The investigators will monitor these effects by performing tests in the laboratory on participants' blood, a lymph node, and tissue from the sites of vaccination.

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

Cyclophosphamide

Cyclophosphamide, systemic adjuvant

Sponsors & Collaborators

  • Ludwig Institute for Cancer Research

    collaborator OTHER

  • Cancer Research Institute, New York City

    collaborator OTHER

  • 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
2015-05-12
Primary Completion
2017-08-18
Completion
2018-01-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT02425306 on ClinicalTrials.gov