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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
The purpose of the study is to see if Nivolumab or Nivolumab in combination with Azacitidine given to patients before and after surgery is safe and to see if patients are able to successfully complete the treatment before their surgery without any extended delays in treatment.
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 Childrens Oncology Group. Phase II Secondary Objective: Efficacy (OS): assess overall survival in patients with recurrent, resectable osteosarcoma patients receiving neoadjuvant therapy. Exploratory Objectives: To determine changes in expression of selected immune markers compared to baseline, in the blood and metastatic tumor tissue from patients receiving neoadjuvant therapy; to determine changes in the quality and quantity of tumor infiltrating lymphocytes; and to compare findings in tumor specimens from treated patients to findings in an existing cohort of untreated patients on a companion tissue collection protocol. To explore the association between Nivolumab +/] Azacitidine exposure and selected pharmaco]dynamic markers in the peripheral blood and in the tumor microenvironment.