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NCT02009397 · ClinicalTrials.gov registry record · Phase 1

A Phase I/II Open-Label Study of Ipilimumab and GM-CSF Administered to Unresectable Stage IIIC and Stage IV Melanoma Patients

A Phase 1 study, sponsored by University of Louisville.

Completed
Registry status
Phase 1
Development phase
27
Enrollment target

NCT02009397 is a Phase 1 study that has completed, run by University of Louisville. The registered enrollment target is 27 participants.

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The verdict

NCT02009397, a Phase 1 study, has completed, sponsored by University of Louisville.

COMPLETED
Registry status
Phase 1
Development phase
27 participants
Enrollment target

Study Summary

The purpose of this study is to test the combination of Ipilimumab and GM-CSF. Both ipilimumab and GM-CSF are intended to work with the body's own immune system to attack melanoma cells in the body. This study will also demostrate how safe the combined drugs are when used to treat patients with Stage 3 or Stage 4 melanoma (metastatic melanoma), which cannot be removed by surgery.

Interventions

  • DRUG Ipilimumab
  • DRUG GM-CSF

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2012-02
Est. Completion 2016-11
Phase Phase 1

Sponsor

University of Louisville

217 total trials

What the Registry Record Tells You About NCT02009397

The ClinicalTrials.gov registry entry for NCT02009397 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Louisville, which has 217 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Ipilimumab is the first listed.

NCT02009397 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02009397 about?

NCT02009397 is a clinical study titled "A Phase I/II Open-Label Study of Ipilimumab and GM-CSF Administered to Unresectable Stage IIIC and Stage IV Melanoma Patients". The purpose of this study is to test the combination of Ipilimumab and GM-CSF. Both ipilimumab and GM-CSF are intended to work with the body's own immune system to attack melanoma cells in the body. This study will also demostrate how safe the combined drugs are when used to treat patients with Stag...

What is the current status of trial NCT02009397?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2012-02. Estimated completion is 2016-11.

What interventions are being tested in trial NCT02009397?

The interventions under investigation include: Ipilimumab (DRUG), GM-CSF (DRUG).

Who is sponsoring clinical trial NCT02009397?

This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.