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A Multipeptide Vaccine Plus Toll-Like Receptor Agonists in Melanoma Patients

NCT01585350 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2016-08-12

No results posted yet for this study

Summary

The purpose of this study is to learn the effects an experimental vaccine (MELITAC 12.1) combined with other substances called lipopolysaccharide (LPS; endotoxin), polyICLC, and Montanide ISA-51. The LPS, polyICLC, and Montanide ISA-51 are included with the vaccine to test whether they have an effect on the MELITAC 12.1 vaccine. The study will also look at whether the experimental vaccine and these drugs cause any changes to the immune system.

Conditions

Interventions

BIOLOGICAL

MELITAC 12.1 + Montanide ISA-51 + lipopolysaccharide (LPS)

Cohort 1 will be divided into three sub-groups and will receive: * Group 1a: MELITAC 12.1 + lipopolysaccharide (LPS) * Group 1b: MELITAC 12.1 + lipopolysaccharide (LPS) + Montanide adjuvant with vaccination #1 * Group 1c: MELITAC 12.1 + lipopolysaccharide (LPS) adjuvant + Montanide adjuvant with all vaccinations

BIOLOGICAL

MELITAC 12.1 + Montanide ISA-51 + polyICLC

Cohort 2 will be divided into three sub-groups and will receive: * Group 2a: MELITAC 12.1 + polyICLC adjuvant * Group 2b: MELITAC 12.1 + polyICLC adjuvant + Montanide adjuvant with vaccination #1 * Group 2c: MELITAC 12.1 + polyICLC adjuvant + Montanide adjuvant with all vaccinations

Sponsors & Collaborators

  • University of Virginia

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Oncovir, Inc.

    collaborator INDUSTRY

  • Craig L Slingluff, Jr

    lead OTHER

Principal Investigators

  • Craig L Slingluff, 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
2012-10-31
Primary Completion
2014-07-31
Completion
2014-10-31

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 NCT01585350 on ClinicalTrials.gov