Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent, Resectable Osteosarcoma
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|ClinicalTrials.gov Identifier: NCT03628209|
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : September 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Osteosarcoma Osteosarcoma in Children Osteosarcoma Recurrent Sarcoma||Drug: Nivolumab Drug: Azacitidine Procedure: Post Treatment Surgery||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||51 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Phase Ib lead-in with extension to Phase II|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 3, 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2023|
Experimental: Dose Escalation, Resection, Dose Expansion
Participants will receive 1 cycle of neoadjuvant Nivolumab or Nivolumab + Azacitidine, followed by surgery to render them in surgical remission. Subsequently they will continue to receive Nivolumab or Nivolumab + Azacitidine for 12 additional cycles or until recurrence, whichever occurs first. Once the recommended Phase II dose (RP2D) is identified during Phase I, the Dose Expansion Phase II will be opened at this dose level. The Phase II portion of the study will consist of a maximum 33 evaluable patients (27-30 in addition to the 3-6 enrolled at RP2D on the Phase I portion).
Participants will be treated with Nivolumab intravenously (IV), 3 mg/kg on days 1 and 15 of each cycle.
Other Name: Opdivo®
Phase I Dose Escalation - Dose level 1: NA. Dose level 2: 60 mg/m^2. Dose level 3: 75 mg/m^2. Phase II Expansion - Treated at recommended Phase II dose (RP2D).
Other Name: Vidaza®
Procedure: Post Treatment Surgery
Resection surgery at end of Cycle 1 treatment, day 28-35.
- Phase I: Recommended Phase II Dose (RP2D) [ Time Frame: 60 days ]If one or fewer dose limiting toxicities (DLT's) occur in 6 participants the study will advance to the next dose level. If 2 or more DLT's occur at a dose level, the prior dose level will be identified as the RP2D.
- Phase II: Rate of Continued Complete Remission (CR) [ Time Frame: 1 year post surgery ]Continued complete remission by computed tomography (CT) scan 1 year after surgery.
- Percentage of Participants with Event Free Survival (EFS) [ Time Frame: 1 year post surgery ]EFS: The time from diagnostic biopsy until the earliest of: death, local recurrence, new metastatic disease, progression of metastatic disease or secondary malignancy, or date of last contact.
- Overall Survival (OS) Rate [ Time Frame: 1 year post surgery ]The percentage of participants alive at 1 year post surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03628209
|Contact: Jessica R Crimella, BSN, RN||813-745-6250||Jessica.Crimella@moffitt.org|
|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|