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Checkpoint Inhibitor

Dose escalation for Osteosarcoma (AflacST2301 Trial)

Phase 1
Waitlist Available
Led By Thomas Cash, MD, MSc
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Participants must have had histologic verification of osteosarcoma at the original diagnosis or relapse
* Participants must be in first or greater relapse of osteosarcoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, end of 1 year
Awards & highlights

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

Who is the study for?
This trial is for patients with osteosarcoma that has come back and spread to the lungs. Participants must be healthy enough for surgery, radiation therapy, and immunotherapy. Specific details about who can join are not provided here.
What is being tested?
The study is testing the safety of combining Atezolizumab (an immunotherapy drug), SBRT (a precise form of radiation therapy), and surgery in patients whose osteosarcoma has returned and spread to their lungs.
What are the potential side effects?
Possible side effects include typical reactions to immunotherapy like fatigue, skin reactions, inflammation in organs; complications from radiation such as localized pain or damage; and risks associated with lung surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, end of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, end of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with Dose limiting toxicity at Dose Level 1
Number of participants with Dose limiting toxicity at Dose Level 2
Secondary study objectives
Disease Control Rate
Overall Survival
Progression-free survival (PFS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose escalationExperimental Treatment3 Interventions
Unilateral: Participants start with atezolizumab, followed ≤ 1 week later by SBRT at the assigned dose for a single lesion. After 2 cycles, those with unilateral disease undergo complete surgical resection, including all lung nodules, including the radiated one, as per osteosarcoma standard care. Atezolizumab resumes 14-28 days post-op, per protocol criteria, barring toxicity or disease progression. Bilateral: Subjects first undergo surgery on the non-SBRT side. 7-14 days later, they start atezolizumab, followed ≤ 1 week later by SBRT on the other lesion. After 2 cycles of atezolizumab, surgery on the contralateral side removes all lung nodules, including the radiated one, per standard care. Atezolizumab resumes 14-18 days post-op, per protocol criteria, barring toxicity or disease progression
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy (SBRT)
2018
Completed Phase 2
~740
Atezolizumab
2017
Completed Phase 3
~5860
Surgical Resection
2018
Completed Phase 2
~420

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,550 Previous Clinical Trials
568,445 Total Patients Enrolled
1 Trials studying Osteosarcoma
43 Patients Enrolled for Osteosarcoma
Emory UniversityLead Sponsor
1,679 Previous Clinical Trials
2,580,029 Total Patients Enrolled
3 Trials studying Osteosarcoma
84 Patients Enrolled for Osteosarcoma
Thomas Cash, MD, MScPrincipal InvestigatorEmory University
1 Previous Clinical Trials
24 Total Patients Enrolled
~8 spots leftby Jun 2027
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