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Pilot Study of Vigil™ + Pembrolizumab for Advanced Melanoma

NCT02574533 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2017-09-27

No results posted yet for this study

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.

Conditions

  • Melanoma Recurrent
  • Malignant Melanoma
  • Melanoma

Interventions

BIOLOGICAL

Vigil

Vigil™ 1 x 10e7 cells via intradermal injection on Day 1, 15, 29, 43 and then every 3 weeks thereafter for a minimum of 4 administrations and a maximum of 9 administrations (depending on the quantity of Vigil™ manufactured from surgical specimens)

DRUG

Pembrolizumab

Pembrolizumab 2mg/kg by intravenous infusion over 30 minute starting on day 43 and every 3 weeks thereafter

Sponsors & Collaborators

  • Gradalis, Inc.

    lead INDUSTRY

Principal Investigators

  • Luisa Manning, MD · Gradalis, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02574533 on ClinicalTrials.gov