NCT06492954

Atezolizumab in Combination With Stereotactic Body Radiation Therapy (SBRT) and Surgery for Relapsed Osteosarcoma

Phase 1b Trial of Atezolizumab in Combination With Stereotactic Body Radiation Therapy (SBRT) and Surgery in Patients With Pulmonary Recurrence of Osteosarcoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteosarcoma
• Pulmonary Recurrence of Osteosarcoma

Interventions

Type	Name	Description
PROCEDURE	Surgical Resection	Removal of all lung nodules, including the radiated nodule, per the standard of care for osteosarcoma patients with lung metastasis.
RADIATION	Stereotactic Body Radiation Therapy (SBRT)	Dose level 1: 8 Gy\* 3 (Total 24 Gy) Dose level 2: 18 Gy\* 3 (Total 54 Gy)
DRUG	Atezolizumab	For subjects \<18 years of age at the time of enrollment, Atezolizumab will be administered IV on Day 1 of each 21-day cycle at a dose of 15 mg/kg (maximum dose of 1200 mg). Subjects ≥ 18 years old will receive a flat dose of 1200 mg IV on Day 1 of each 21-day cycle

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2024-07-09
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study