A Phase I/II Trial to Evaluate the Safety and Immunogenicity of a Helper Peptide Vaccine Plus CTLA-4 Blockade in Melanoma Patients (Mel62; 6PAC)

NCT02385669 Phase 1/Phase 2 TERMINATED Results posted

This study evaluates whether it is safe to administer a peptide vaccine with ipilimumab. This study will also evaluate the effects of the combination of the peptide vaccine and ipilimumab on the immune system. The investigators will monitor these effects by performing tests in the laboratory on participants' blood, a lymph node, and tumor samples.

Details

Lead sponsor	Craig L Slingluff, Jr
Phase	Phase 1/Phase 2
Status	TERMINATED
Enrolment	3
Start date	2015-04
Completion	2019-09-18

Conditions

• Melanoma

Interventions

• Ipilimumab
• 6MHP

Primary outcomes

• Safety (Adverse Event Profile) — 30 days after the last vaccination
  Adverse event profile for the combination of ipilimumab and 6MHP
• CD4+ T Cell Responses in the Blood and in the Sentinel Immunized Node — through day 92
  CD4+ T cell responses to the peptide vaccine, defined as: 1. any CD4+ T cell response to 6 melanoma helper peptides (6MHP) in peripheral blood mononuclear cells (PBMC) with a 10 fold (or greater) increase in response over background (high response) by ex vivo ELIspot assay. 2. CD4+ T cell high responses to 6MHP in PBMC at at least 2 consecutive time points having peripheral blood mononuclear cells (PBMC) with a 10 fold (or greater) increase in response over background by ex vivo ELIspot assay. 3. CD4+ T cell high response to 6MHP in sentinel immunized lymph node (SIN).

Countries

United States