At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 22 enrolled
Drug / intervention
6MHP +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Trial to Evaluate the Safety, Immunogenicity, and Clinical Activity of a Helper Peptide Vaccine Plus PD-1 Blockade
In Brief
A Phase 2 clinical trial evaluating 6MHP and Pembrolizumab for Melanoma. Completed, enrolled 22 participants across 1 site.
Detailed Summary
This study evaluates whether it is safe to administer a peptide vaccine in combination with pembrolizumab. This study will also evaluate the effects of the combination of the peptide vaccine and pembrolizumab 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 2015
Enrollment StartOct 2016
Primary CompletionMar 2020
TodayJul 2026
First PostedAug 4, 2015
Enrollment StartOct 6, 2016
Primary CompletionMar 14, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.9 years ago
Interventions
6MHPbiological
6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
Pembrolizumabdrug
Humanized monoclonal antibody (mAb) specific for PD-1.