Ignite Creation Date:
2024-07-17 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492954
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-21
Brief Title:
Atezolizumab in Combination with Stereotactic Body Radiation Therapy SBRT and Surgery for Relapsed Osteosarcoma
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Phase 1b Trial of Atezolizumab in Combination with Stereotactic Body Radiation Therapy SBRT and Surgery in Patients with Pulmonary Recurrence of Osteosarcoma
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AflacST2301
Brief Summary:
This study aims to determine the safety and tolerability of combined Atezolizumab stereotactic body radiation therapy SBRT and surgical resection of pulmonary metastases in patients with pulmonary recurrence of osteosarcoma
Detailed Description:
The overall survival at 5 years after recurrence of OS ranges from 16 to 23 in most studies highlighting the need for novel treatment approaches Aggressive surgical resection is the standard of care for resectable osteosarcoma recurrences limited to the lung While previous studies testing immune checkpoint inhibitors ICIs in osteosarcoma have shown limited efficacy preclinical osteosarcoma studies demonstrate improved outcomes when ICIs are combined with radiation and administered with minimal residual disease The proposed research will be a single-arm safety pilot evaluating the safety tolerability and preliminary efficacy of Atezolizumab in combination with SBRT and surgery in patients with resectable lung-only recurrence of osteosarcoma
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?:
True
Is an FDA AA801 Violation?:
None