Atezolizumab in Combination With Stereotactic Body Radiation Therapy (SBRT) and Surgery for Relapsed Osteosarcoma
NCT06492954 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2026-03-02
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
Conditions
- Osteosarcoma
- Pulmonary Recurrence of Osteosarcoma
Interventions
- 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
-
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
Sponsors & Collaborators
-
Genentech, Inc.
collaborator INDUSTRY -
Emory University
lead OTHER
Principal Investigators
-
Thomas Cash, MD, MSc · Emory University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-31
- Primary Completion
- 2027-06-30
- Completion
- 2027-06-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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