Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists
NCT02126579 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2024-02-28
Summary
The purpose of this study is to learn what effects (good and bad) an experimental vaccine (LPV7) plus tetanus peptide and other substances called polyICLC, resiquimod, and Montanide ISA-51 have on you and your melanoma. We will also look at whether the experimental vaccine and these drugs cause any changes in your immune system.
Conditions
- Melanoma
- Metastatic Melanoma
- Mucosal Melanoma
Interventions
- BIOLOGICAL
-
Peptide Vaccine (LPV7) + Tetanus peptide
1.5 mL administered half intradermally and half subcutaneously.
- OTHER
-
PolyICLC
1 mL administered half intradermally and half subcutaneously
- OTHER
-
Resiquimod
500 mg applied to vaccine site after vaccine administration
- OTHER
-
IFA
2 mL administered half intradermally and half subcutaneously
Sponsors & Collaborators
-
University of Virginia
collaborator OTHER -
Craig L Slingluff, Jr
lead OTHER
Principal Investigators
-
Craig L Slingluff, Jr., M.D. · 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
- 2014-05-01
- Primary Completion
- 2019-11-20
- Completion
- 2021-05-05
Countries
- United States
Study Locations
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