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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: Active Phase 1 study of Sarcoma and Osteosarcoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
If one or fewer dose limiting toxicities (DLT's) occur in 6 participants the study will advance to the next dose level. If 2 or more DLT's occur at a dose level, the prior dose level will be identified as the RP2D.
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 |
What the registry record for NCT03628209 still lists
NCT03628209 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 921-participant average among 122 other Sarcoma trials with a reported enrollment target (98% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
Similar trials for Sarcoma
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 NCT03628209's enrollment target sits among peer trials
21 100th of 122 higher than 23 of 122 other Sarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sarcoma 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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