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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: Completed Phase 1 study, sponsored by Roswell Park Cancer Institute.
NCT03358719 is a Phase 1 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will evaluate the proportion of n=8 evaluable patients in the expansion cohort experiencing a dose-limiting toxicity. Toxicity rates will be described using upper 1-sided 95% Jeffreys binomial confidence intervals.
Interventions
- DRUG Decitabine
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Nivolumab
- DRUG Poly ICLC
- BIOLOGICAL DEC-205/NY-ESO-1 Fusion Protein CDX-1401
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-03-27 |
| Est. Completion | 2021-08-25 |
| Phase | Phase 1 |
What the finished NCT03358719 record still lists
NCT03358719 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 5 interventions - of which Decitabine is the first listed.
NCT03358719 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03358719's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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