Pilot Study of Vigil™ + Pembrolizumab for Advanced Melanoma
Status:
Completed
Trial end date:
2017-09-01
Target enrollment:
Participant gender:
Summary
This is an open label Pilot study to evaluate the combination of Vigil™ and pembrolizumab in
patients with incurable locally advanced or metastatic melanoma. Patients undergoing a
standard of care surgical procedure (e.g., tumor biopsy, palliative resection) and meeting
procurement eligibility criteria may have tumor harvested for Vigil™ vaccine manufacture.
This study evaluates the hypothesis that vaccination with Vigil™ will induce cancer-specific
T cell immunity in these patients. Addition of pembrolizumab to Vigil™ treated patients will
further augment these immune changes on sequential biopsy when comparing post-Vigil™ but
pre-PD-1 inhibitor to post-PD-1 inhibitor biopsies, and the combination therapy will be
associated with reduction of tumor volume on clinical exam and/or imaging.