NCT03617328

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

Evaluation of Safety and Durable Immunogenicity of Melanoma Vaccination, With or Without Systemic CDX-1127, in Patients With Stage II-IV Melanoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Craig L Slingluff, Jr · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Melanoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-11-13
• Primary completion: 2024-01-19
• Completion: 2024-01-19
• First posted: 2018-08-06
• Last updated: 2024-02-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study