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NCT02574533 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of Vigil™ + Pembrolizumab for Advanced Melanoma
A Phase 1 study of Melanoma and Malignant Melanoma, sponsored by Gradalis.
- Completed
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
- 3
- Study locations
NCT02574533 is a Phase 1 study of Melanoma and Malignant Melanoma that has completed, run by Gradalis. The registered enrollment target is 2 participants, below the 707-participant average among 266 other Melanoma trials with a reported enrollment target (100% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT02574533, a Phase 1 study of Melanoma and Malignant Melanoma, has completed, sponsored by Gradalis.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
- 3
- Study locations
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 Studied
Interventions
- DRUG Pembrolizumab
- BIOLOGICAL Vigil
Study Locations (3)
Texas
- Texas Oncology P.A., Texas Cancer Center - Abilene
- Mary Crowley Medical Research Centers - Dallas
Washington
- Cancer Care Northwest - Spokane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2015-10 |
| Est. Completion | 2017-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02574533
The ClinicalTrials.gov registry entry for NCT02574533 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 707-participant average among 266 other Melanoma trials with a reported enrollment target (100% lower). The listed sponsor is Gradalis, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT02574533 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Texas, Washington.
Frequently Asked Questions
What is clinical trial NCT02574533 about?
NCT02574533 is a clinical study titled "Pilot Study of Vigil™ + Pembrolizumab for Advanced Melanoma". 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 crite...
What is the current status of trial NCT02574533?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2015-10. Estimated completion is 2017-09.
What conditions does trial NCT02574533 study?
This clinical trial studies the following conditions: Melanoma, Malignant Melanoma, Melanoma Recurrent.
What interventions are being tested in trial NCT02574533?
The interventions under investigation include: Pembrolizumab (DRUG), Vigil (BIOLOGICAL).
Who is sponsoring clinical trial NCT02574533?
This trial is sponsored by Gradalis, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02574533 being conducted?
This trial has 3 study locations across Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.