Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Osteosarcoma
- Osteosarcoma in Children
- Osteosarcoma Recurrent
- Sarcoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Phase Ib lead-in with extension to Phase IIMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 39 years
- Gender
- Both males and females
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, which...
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.
Tracking Information
- NCT #
- NCT03628209
- Collaborators
- Bristol-Myers Squibb
- Investigators
- Principal Investigator: Patrick A. Thompson, MD University of North Carolina, Chapel Hill Principal Investigator: Mihaela M Druta, MD H. Lee Moffitt Cancer Center and Research Institute, Coordinating Center
Get Well Soon