NCT02126579

Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists

Open Label, Randomized, Phase I/II Study of a Long Peptide Vaccine Plus TLR Agonists for Resected Stage IIb-IV Melanoma. (MEL60)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Craig L Slingluff, Jr · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2014-05-01
• Primary completion: 2019-11-20
• Completion: 2021-05-05
• First posted: 2014-04-30
• Last updated: 2024-02-28
• Results posted: 2023-11-03

Locations

2 sites across 1 country: United States