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RECRUITING
NCT06492954
PHASE1

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

Sponsor: Emory University

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

Any - 50 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-03

Completion Date

2027-06

Last Updated

2026-03-02

Healthy Volunteers

No

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

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

Locations (1)

Chilldren's Healthcare of Atlanta

Atlanta, Georgia, United States