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NCT03358719 · ClinicalTrials.gov registry record · Phase 1

DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

A Phase 1 study, sponsored by Roswell Park Cancer Institute.

Completed
Registry status
Phase 1
Development phase
8
Enrollment target

NCT03358719 is a Phase 1 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 8 participants.

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The verdict

NCT03358719, a Phase 1 study, has completed, sponsored by Roswell Park Cancer Institute.

COMPLETED
Registry status
Phase 1
Development phase
8 participants
Enrollment target

Study Summary

This phase I trial studies the side effects of DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, decitabine, and nivolumab in treating patients with myelodysplastic syndrome or acute myeloid leukemia. DEC-205/NY-ESO-1 fusion protein CDX-1401 is a vaccine that may help the immune system specifically target and kill cancer cells. Poly ICLC may help stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as nivolumab, may interfere with the ability of cancer cells to grow and spread. Giving DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, decitabine, and nivolumab may work better in treating patients with myelodysplastic syndrome or acute myeloid leukemia.

Interventions

  • DRUG Decitabine
  • OTHER Laboratory Biomarker Analysis
  • BIOLOGICAL Nivolumab
  • DRUG Poly ICLC
  • BIOLOGICAL DEC-205/NY-ESO-1 Fusion Protein CDX-1401

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2018-03-27
Est. Completion 2021-08-25
Phase Phase 1

Sponsor

Roswell Park Cancer Institute

365 total trials

What the Registry Record Tells You About NCT03358719

The ClinicalTrials.gov registry entry for NCT03358719 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roswell Park Cancer Institute, which has 365 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Decitabine is the first listed.

NCT03358719 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03358719 about?

NCT03358719 is a clinical study titled "DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia". This phase I trial studies the side effects of DEC-205/NY-ESO-1 fusion protein CDX-1401, poly ICLC, decitabine, and nivolumab in treating patients with myelodysplastic syndrome or acute myeloid leukemia. DEC-205/NY-ESO-1 fusion protein CDX-1401 is a vaccine that may help the immune system specifical...

What is the current status of trial NCT03358719?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2018-03-27. Estimated completion is 2021-08-25.

What interventions are being tested in trial NCT03358719?

The interventions under investigation include: Decitabine (DRUG), Laboratory Biomarker Analysis (OTHER), Nivolumab (BIOLOGICAL), Poly ICLC (DRUG), DEC-205/NY-ESO-1 Fusion Protein CDX-1401 (BIOLOGICAL).

Who is sponsoring clinical trial NCT03358719?

This trial is sponsored by Roswell Park Cancer Institute, which has 365 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.