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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.

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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

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

FieldValue
Enrollment Target 21 participants
Start Date 2019-10-03
Est. Completion 2026-04
Phase Phase 1

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

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.