RecruitingPhase 1NCT06492954

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

Sponsor

Emory University

Enrollment

12 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

Osteosarcoma Pulmonary Recurrence of Osteosarcoma

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

Eligibility

Max Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether combining an immunotherapy drug (atezolizumab) with targeted radiation (SBRT) before surgery can improve outcomes for young people whose osteosarcoma (bone cancer) has spread to the lungs. **You may be eligible if...** - You have been diagnosed with osteosarcoma that has come back and spread to the lungs only - Your lung tumors can be surgically removed without removing an entire lung - You are able to tolerate the study treatment and surgery - You meet the required blood count and organ function thresholds **You may NOT be eligible if...** - Your cancer has spread outside the lungs - Your tumors cannot be safely removed by surgery - You have previously received atezolizumab or a similar immunotherapy - You have active autoimmune disease or are on immunosuppressive medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESurgical Resection

Removal of all lung nodules, including the radiated nodule, per the standard of care for osteosarcoma patients with lung metastasis.

RADIATIONStereotactic Body Radiation Therapy (SBRT)

Dose level 1: 8 Gy\* 3 (Total 24 Gy) Dose level 2: 18 Gy\* 3 (Total 54 Gy)

DRUGAtezolizumab

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