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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: Completed Phase 1 study of Melanoma and Malignant Melanoma, sponsored by Gradalis.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Tumor Immune-Related Response to Vigil and Vigil + Pembrolizumab as measured by Tumor biopsy for Immunohistochemistry

Conditions Studied

Melanoma Malignant Melanoma Melanoma Recurrent

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

FieldValue
Enrollment Target 2 participants
Start Date 2015-10
Est. Completion 2017-09
Phase Phase 1
Gradalis

13 total trials

What the finished NCT02574533 record still lists

NCT02574533 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 707-participant average among 266 other Melanoma trials with a reported enrollment target (100% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Melanoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02574533's enrollment target sits among peer trials

2 266th of 266 the lowest of 266 other Melanoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02574533, the US trial registry maintained by the National Library of Medicine. NCT02574533 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.