Atezolizumab + Radiation + Surgery for Osteosarcoma

(AflacST2301 Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Thomas Cash, MD, MSc

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Emory University

Must not be taking: Immunosuppressants, others

Disqualifiers: Pregnancy, Extrapulmonary metastases, Autoimmune disorders, others

No Placebo Group

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, there are specific time requirements for stopping certain treatments like chemotherapy, growth factors, and other therapies before joining. It's best to discuss your current medications with the trial team to get a clear answer.

What data supports the effectiveness of the drug Atezolizumab in combination with radiation and surgery for osteosarcoma?

Atezolizumab, when used for bladder cancer, has shown significant tumor responses and improved survival rates, suggesting its potential effectiveness in other cancers. Additionally, combining Atezolizumab with radiation therapy has shown promising early responses in lung cancer, indicating that this combination might enhance treatment outcomes in osteosarcoma as well. ^{1 2 3 4 5}

Is the combination of Atezolizumab, Radiation, and Surgery generally safe for humans?

Atezolizumab, also known as Tecentriq, has been shown to have a favorable safety profile in various studies for different types of cancer, including bladder cancer and non-small cell lung cancer. It is generally considered safe, with ongoing trials to further assess its safety in combination with other treatments like radiation. ^{1 3 5 6 7}

How does the drug atezolizumab differ from other treatments for osteosarcoma?

Atezolizumab is unique because it is a monoclonal antibody that targets PD-L1, a protein that helps cancer cells evade the immune system, thereby boosting the body's immune response against tumors. This approach is different from traditional chemotherapy or surgery, as it specifically enhances the immune system's ability to fight cancer cells. ^{1 3 4 5 8}

Research Team

Thomas Cash, MD, MSc

Principal Investigator

Emory University

Eligibility Criteria

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.

Inclusion Criteria

Any side effects from my previous treatments are mild or stable.

My liver is working well.

My bone marrow is functioning well.

Exclusion Criteria

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

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

I have had pneumonitis before or have it now.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Atezolizumab followed by SBRT and surgical resection of pulmonary metastases

2 cycles of Atezolizumab, followed by surgery and resumption of Atezolizumab 14-28 days post-op

Follow-up

Participants are monitored for safety, tolerability, and disease progression

12 months

Treatment Details

Interventions

• Atezolizumab (Checkpoint Inhibitor)
• Stereotactic Body Radiation Therapy (SBRT) (Radiation)
• Surgical Resection (Procedure)

Trial Overview 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.

Participant Groups

Group I: Dose escalation Experimental Treatment 3 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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Chilldren's Healthcare of Atlanta Atlanta, GA

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1735

Patients Recruited

2,605,000+

Genentech, Inc.

Industry Sponsor

Trials

1578

Patients Recruited

569,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. Inman, BA., Longo, TA., Ramalingam, S., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab plus stereotactic ablative radiotherapy for medically inoperable patients with early-stage non-small cell lung cancer: a multi-institutional phase I trial. Monjazeb, AM., Daly, ME., Luxardi, G., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Bladder Preservation Therapy in Combination with Atezolizumab and Radiation Therapy (BPT-ART) for Invasive Bladder Cancer: Interim Analysis from a Multicenter, Open-label, Prospective Phase 2 Trial. Kimura, T., Ishikawa, H., Nagumo, Y., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Rittmeyer, A., Barlesi, F., Waterkamp, D., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. Markham, A.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Atezolizumab Monotherapy in Previously Treated Japanese Patients With Unresectable Advanced or Recurrent NSCLC: A Multicenter, Prospective, Observational Study (J-TAIL). Miura, S., Nishio, M., Akamatsu, H., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atezolizumab as the First Systemic Therapy Approved for Alveolar Soft Part Sarcoma. Bergsma, EJ., Elgawly, M., Mancuso, D., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term survival in patients with advanced non-small-cell lung cancer treated with atezolizumab versus docetaxel: Results from the randomised phase III OAK study. von Pawel, J., Bordoni, R., Satouchi, M., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Atezolizumab: A PD-L1-Blocking Antibody for Bladder Cancer. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Atezolizumab plus stereotactic ablative radiotherapy for medically inoperable patients with early-stage non-small cell lung cancer: a multi-institutional phase I trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Bladder Preservation Therapy in Combination with Atezolizumab and Radiation Therapy (BPT-ART) for Invasive Bladder Cancer: Interim Analysis from a Multicenter, Open-label, Prospective Phase 2 Trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Atezolizumab: First Global Approval. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Atezolizumab Monotherapy in Previously Treated Japanese Patients With Unresectable Advanced or Recurrent NSCLC: A Multicenter, Prospective, Observational Study (J-TAIL). [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Atezolizumab as the First Systemic Therapy Approved for Alveolar Soft Part Sarcoma. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Long-term survival in patients with advanced non-small-cell lung cancer treated with atezolizumab versus docetaxel: Results from the randomised phase III OAK study. [2022]