Atezolizumab +/- Bevacizumab for Alveolar Soft Part Sarcoma

Recruiting at 46 trial locations

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: National Cancer Institute (NCI)

Must not be taking: Immunosuppressants, NSAIDs, others

Disqualifiers: CNS metastases, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 22

Duration: Up to 2 years

63 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, certain medications like systemic immunosuppressive drugs and some investigational agents must be stopped before starting the trial. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug Atezolizumab +/- Bevacizumab for Alveolar Soft Part Sarcoma?

Atezolizumab has been approved for treating alveolar soft part sarcoma, showing effectiveness in both adults and children. Bevacizumab, when used alone, has also shown positive results in patients with this type of cancer, suggesting that these drugs may be beneficial when used together. ^{1 2 3 4 5}

Is the combination of Atezolizumab and Bevacizumab safe for humans?

Atezolizumab (Tecentriq) and Bevacizumab (Avastin) have been studied for safety in various conditions. Atezolizumab is approved for use in certain cancers, and Bevacizumab has shown safety in treating a 90-year-old patient with alveolar soft part sarcoma, resulting in improved symptoms and disease response. ^{1 2 4 5 6}

How is the drug combination of Atezolizumab and Bevacizumab unique for treating alveolar soft part sarcoma?

The combination of Atezolizumab (an immune checkpoint inhibitor) and Bevacizumab (a drug targeting blood vessel growth) is unique for treating alveolar soft part sarcoma because it combines immune system activation with inhibition of blood supply to the tumor, offering a novel approach for a condition that is typically resistant to standard chemotherapy. ^{1 2 3 4 5}

What is the purpose of this trial?

This phase II trial studies how well atezolizumab or atezolizumab plus bevacizumab works in treating patients with alveolar soft part sarcoma that has not been treated, has spread from where it started to other places in the body (advanced) and cannot be removed by surgery (unresectable). Atezolizumab works by unblocking the immune system, allowing the immune system cells to recognize and then attack tumor cells. Bevacizumab works by controlling the growth of new blood vessels. Giving atezolizumab alone or atezolizumab with bevacizumab may shrink the cancer.

Research Team

Alice P Chen

Principal Investigator

National Cancer Institute LAO

Eligibility Criteria

This trial is for people with advanced alveolar soft part sarcoma that can't be removed by surgery. Participants must have certain blood cell counts, organ function levels, and a life expectancy over 3 months. They should not have had recent severe infections or major surgeries, and cannot be pregnant or breastfeeding. Adults and children over 2 years old may join; however, only adults can receive the combination treatment.

Inclusion Criteria

I don't have issues with wound healing, heart conditions, stomach problems, or allergies to medications.

My alveolar soft part sarcoma cannot be cured with surgery.

My condition worsened after taking atezolizumab alone.

Exclusion Criteria

Patients with certain medical conditions or history are excluded from the trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive atezolizumab or atezolizumab plus bevacizumab intravenously every 21 days

Up to 2 years

Every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

27-30 days

1 visit (in-person)

Long-term follow-up

Participants who are progression-free at the end of a 2-year treatment holiday are followed every 6 months

Every 6 months

Treatment Details

Interventions

• Atezolizumab
• Bevacizumab

Trial Overview Researchers are testing if atezolizumab alone or combined with bevacizumab is effective in treating this type of sarcoma. Atezolizumab aims to boost the immune system's ability to fight cancer cells while bevacizumab targets tumor blood supply.

Participant Groups

Group I: Arm II (atezolizumab, bevacizumab) Experimental Treatment 4 Interventions

Patients receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT imaging, and collection of blood and urine at baseline.

Group II: Arm I (atezolizumab) Experimental Treatment 3 Interventions

Patients receive atezolizumab IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT imaging, and collection of blood and urine at baseline. (CLOSED TO ACCRUAL)

Atezolizumab is already approved in United States, European Union for the following indications:

Approved in United States as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Approved in European Union as Tecentriq for:

• Melanoma
• Hepatocellular carcinoma
• Small cell lung cancer
• Non-small cell lung cancer
• Urothelial carcinoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Findings from Research

Atezolizumab (Tecentriq) is an FDA-approved treatment for unresectable or metastatic alveolar soft part sarcoma (ASPS), showing a 24% overall response rate in a clinical trial with 49 patients, and a durable response rate of 67% at 6 months and 42% at 12 months.

The treatment has a manageable safety profile, with common severe side effects including musculoskeletal pain (8%) and hypertension (6%), making it a viable option for patients with limited treatment alternatives for this high-risk disease.

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]

References

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

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

2. Switzerland pubmed.ncbi.nlm.nih.gov

Metastatic Alveolar Soft Part Sarcoma Responsive to Pazopanib after Progression through Sunitinib and Bevacizumab: Two Cases. [2020]

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

Response to Immune Checkpoint Inhibition in Two Patients with Alveolar Soft-Part Sarcoma. [2019]

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

Durable clinical activity of single-agent bevacizumab in a nonagenarian patient with metastatic alveolar soft part sarcoma. [2016]

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

Much Ado about ASPS: The Rapidly Changing Treatment Paradigms of 2022. [2023]

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

Randomized Phase II Trial of Sunitinib or Cediranib in Alveolar Soft Part Sarcoma. [2023]