Pilot Study of Vigil™ + Pembrolizumab for Advanced Melanoma
Completed · Phase 1
Conditions studied: Melanoma Recurrent, Malignant Melanoma, Melanoma
In brief
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.
Key facts
- Study ID
- NCT02574533
- Run by
- Gradalis, Inc.
- People needed
- 2
- Starts
- 2015-10-01
- Expected to finish
- 2017-09-01
- Last updated by the study team
- 2017-09-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Texas Oncology P.A., Texas Cancer Center — Abilene, Texas, United States
- Mary Crowley Medical Research Centers — Dallas, Texas, United States
- Cancer Care Northwest — Spokane, Washington, United States
Full record on ClinicalTrials.gov
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