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NCT03628209 · ClinicalTrials.gov registry record · Phase 1
Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma
A Phase 1 study of Sarcoma and Osteosarcoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 20
- Study locations
NCT03628209 is a Phase 1 study of Sarcoma and Osteosarcoma that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 21 participants, below the 921-participant average among 122 other Sarcoma trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT03628209, a Phase 1 study of Sarcoma and Osteosarcoma, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and efficacy of nivolumab, or nivolumab in combination with azacitidine in participants with recurrent, resectable osteosarcoma
Conditions Studied
Interventions
- DRUG Azacitidine
- DRUG Nivolumab
- PROCEDURE Post Treatment Surgery
Study Locations (20)
Florida
- Shand's Hospital for Children at the University of Florida - Gainesville
- Nemours Children's Hospital - Jacksonville
- University of Miami - Sylvester Comprehensive Cancer Center - Miami
- Nemours Children's Clinic - Orlando
- Johns Hopkins All Children's Hospital - St. Petersburg
- H. Lee Moffitt Cancer Center and Research Institute, Coordinating Center - Tampa
North Carolina
- University of North Carolina at Chapel Hill, UNC Lineberger Comprehensive Cancer Center - Chapel Hill
- Carolina Medical Center, Levine Cancer Institute - Charlotte
- Duke Health - Durham
Ohio
- Cleveland Clinic - Cleveland
- Nationwide Children's Hospital - Columbus
Alabama
- University of Alabama at Birmingham - Birmingham
California
- Children's Hospital of Los Angeles, USC Norris Comprehensive Cancer Center - Los Angeles
Colorado
- Children's Hospital of Colorado - Aurora
Connecticut
- Connecticut Children's Medical Center - Hartford
Delaware
- Alfred I DuPont Hospital for Children - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2019-10-03 |
| Est. Completion | 2026-04 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03628209
The ClinicalTrials.gov registry entry for NCT03628209 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 921-participant average among 122 other Sarcoma trials with a reported enrollment target (98% lower). The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Sarcoma appearing as the primary indexed condition, and to 3 interventions - of which Azacitidine is the first listed.
NCT03628209 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, North Carolina, Ohio.
Frequently Asked Questions
What is clinical trial NCT03628209 about?
NCT03628209 is a clinical study titled "Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma". The purpose of this study is to evaluate the safety and efficacy of nivolumab, or nivolumab in combination with azacitidine in participants with recurrent, resectable osteosarcoma
What is the current status of trial NCT03628209?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2019-10-03. Estimated completion is 2026-04.
What conditions does trial NCT03628209 study?
This clinical trial studies the following conditions: Sarcoma, Osteosarcoma, Osteosarcoma Recurrent, Osteosarcoma in Children.
What interventions are being tested in trial NCT03628209?
The interventions under investigation include: Azacitidine (DRUG), Nivolumab (DRUG), Post Treatment Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT03628209?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03628209 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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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.