Grants and Contracts Details
A Phase Ib/II Study to Evaluate the Safety, Feasibility and Efficacy of Nivolumab or Nivolumab in Combination with 5-Azacytidine in Patients with Recurrent, Resectable Osteosarcoma. Phase I Objective: investigate the safety and feasibility of Nivolumab in combination with Azacitidine given neo-adjuvantly and adjuvantly in subjects with recurrent, resectable osteosarcoma. Feasibility will be evaluated as the successful completion of preoperative treatment and proceeding to surgery without any extended treatment related delays defined as >50 days from preplanned Day 0 in this context. Phase II Primary Objective: Efficacy (EFS): determine if the combination of Azacitidine and Nivolumab, administered both neo-adjuvantly and adjuvantly, improve event free survival to 40% compared to the 20% 12-month historical control used for recurrent osteosarcoma studies in the Children’s Oncology Group. Phase II Secondary Objective: Efficacy (OS): assess overall survival in patients with recurrent, resectable osteosarcoma patients receiving neoadjuvant therapy.
|Effective start/end date||1/21/20 → 8/3/24|
- H Lee Moffitt Cancer Center and Research Institute Hospital: $5,238.00
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