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Checkpoint Inhibitor

Atezolizumab + Radiation + Surgery for Osteosarcoma (AflacST2301 Trial)

Phase 1

Recruiting

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 at least 1 lesion that is ≥ 5 mm and meets the criteria to receive SBRT AND an additional nodule(s) that meets protocol definition for a metastatic nodule necessitating surgical resection

Patients must have a Lansky (≤ 16 years) or Karnofsky (> 16 years) score of ≥ 60, or ECOG performance score of ≤ 2

Must not have

Prior allogeneic stem cell transplant or solid organ transplant

Known history of HIV, hepatitis B, and/or hepatitis C

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, end of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test if a combination of Atezolizumab, radiation therapy, and surgery is safe and well-tolerated for patients with osteosarcoma that has spread to

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

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I have at least one tumor ≥ 5 mm suitable for SBRT and another that requires surgery.

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I can do most activities, but may need help.

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My bone marrow is functioning well.

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My pancreas is functioning well.

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My osteosarcoma was confirmed through tissue examination.

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My osteosarcoma has returned at least once.

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My lung nodules can be surgically removed, as confirmed by a surgeon.

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My lungs are working well.

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I am using effective birth control during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a stem cell or organ transplant in the past.

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I have a history of HIV, hepatitis B, or hepatitis C.

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I have had pneumonitis before or have it now.

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I have been treated with drugs that boost the immune system.

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I do not have any infections that aren't responding to treatment.

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My cancer has spread beyond my lungs.

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I have a mild buildup of fluid in the lining of my lungs.

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I have had radiation therapy to my lung before.

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I have active tuberculosis.

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I regularly use medication that weakens my immune system.

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I have not received a live vaccine in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, end of 1 year

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Atezolizumab

2016

Completed Phase 3

~5860

Surgical Resection

2018

Completed Phase 2

~420