Spots Global Cancer Trial Database for Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma
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Trial Identification
Brief Title: Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma
Official Title: A Phase Ib/II Study to Evaluate the Safety, Feasibility and Efficacy of Nivolumab or Nivolumab in Combination With Azacitidine in Patients With Recurrent, Resectable Osteosarcoma
Study ID: NCT03628209
Study Description
Brief 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
Detailed Description: Treatment will be administered in 28 day cycles with the first cycle in the neoadjuvant setting. This will be followed by surgery to render the participant in surgical remission. Subsequently the participant will continue to receive treatment for up to 12 additional cycles or until recurrence, whichever occurs first. For participants with known bilateral lung recurrence, the nodule\[s\] in one lung should be resected, prior to the first cycle of chemotherapy.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Children's Hospital of Los Angeles, USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
Children's Hospital of Colorado, Aurora, Colorado, United States
Connecticut Children's Medical Center, Hartford, Connecticut, United States
Alfred I DuPont Hospital for Children, Wilmington, Delaware, United States
Shand's Hospital for Children at the University of Florida, Gainesville, Florida, United States
Nemours Children's Hospital, Jacksonville, Florida, United States
University of Miami - Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Nemours Children's Clinic, Orlando, Florida, United States
Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Coordinating Center, Tampa, Florida, United States
University of Kentucky, Markey Cancer Center, Lexington, Kentucky, United States
Johns Hopkins University, Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Roswell Park Comprehensive Cancer Center, Buffalo, New York, United States
University of North Carolina at Chapel Hill, UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Carolina Medical Center, Levine Cancer Institute, Charlotte, North Carolina, United States
Duke Health, Durham, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Patrick A. Thompson, MD
Affiliation: University of North Carolina, Chapel Hill
Role: PRINCIPAL_INVESTIGATOR
Name: Mihaela M Druta, MD
Affiliation: H. Lee Moffitt Cancer Center and Research Institute, Coordinating Center
Role: PRINCIPAL_INVESTIGATOR
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