Ignite Creation Date:
2024-05-06 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03628209
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-06
First Post:
2018-08-08
Brief Title:
Nivolumab or Nivolumab and Azacitidine in Patients With Recurrent Resectable Osteosarcoma
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase IbII Study to Evaluate the Safety Feasibility and Efficacy of Nivolumab or Nivolumab in Combination With Azacitidine in Patients With Recurrent Resectable Osteosarcoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 nodules in one lung should be resected prior to the first cycle of chemotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CA209-9WW | OTHER | Bristol-Myers Squibb Protocol | None |