Atezolizumab +/- Bevacizumab for Alveolar Soft Part Sarcoma

Not currently recruiting at 48 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the drugs atezolizumab and bevacizumab in treating alveolar soft part sarcoma, a type of cancer that cannot be surgically removed and has metastasized. Atezolizumab helps the immune system recognize and attack cancer cells, while bevacizumab inhibits the growth of new blood vessels that nourish tumors. The study includes two groups: one receiving only atezolizumab and another receiving both atezolizumab and bevacizumab. Individuals with advanced alveolar soft part sarcoma that has progressed and cannot be surgically removed may be suitable for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant cancer research.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that atezolizumab is generally well-tolerated and may help treat alveolar soft part sarcoma. In earlier studies, about one-third of patients experienced tumor shrinkage without severe side effects. The treatment is approved for other conditions, indicating its general safety.

Adding bevacizumab to atezolizumab appears to enhance effectiveness. However, some risks exist. Serious side effects can occur, though they are uncommon. Participants should understand these risks and discuss them with their doctor.

Overall, both atezolizumab alone and in combination with bevacizumab have demonstrated promising results in past studies, with an acceptable safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because atezolizumab and bevacizumab offer a new approach for treating alveolar soft part sarcoma. Unlike traditional chemotherapy that attacks rapidly dividing cells indiscriminately, atezolizumab is an immunotherapy that helps the immune system recognize and destroy cancer cells by blocking the PD-L1 protein. Bevacizumab, on the other hand, targets the blood vessels that supply tumors, potentially starving them of nutrients. This combination could provide a more targeted and effective treatment option with fewer side effects compared to conventional therapies.

What evidence suggests that this trial's treatments could be effective for alveolar soft part sarcoma?

Research has shown that atezolizumab, which participants in this trial may receive, effectively treats alveolar soft part sarcoma, a rare type of cancer. In studies, it reduced tumor size in nearly 40% of patients, and about one-third experienced long-lasting positive responses. Another treatment option in this trial combines atezolizumab with bevacizumab. This combination helps the immune system fight cancer and controls the growth of blood vessels that feed the tumor. Although limited data exist on its effectiveness specifically for alveolar soft part sarcoma, these actions offer hope for its potential success. ^{1 2 4 6 7}

Who Is on the Research Team?

Alice P Chen

Principal Investigator

National Cancer Institute LAO

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2303383

Atezolizumab for Advanced Alveolar Soft Part Sarcoma Atezolizumab was effective at inducing sustained responses in approximately one third of patients with advanced ASPS.

2. cancer.gov cancer.gov/news-events/cancer-currents-blog/2023/atezolizumab-effective-alveolar-soft-part-sarcoma

Atezolizumab Shrinks Alveolar Soft Part Sarcomas - NCI Treatment with atezolizumab (Tecentriq) shrank tumors in nearly 40% of people with alveolar soft part sarcoma, according to new clinical ...

3. fda.gov fda.gov/drugs/resources-information-approved-drugs/fda-grants-approval-atezolizumab-alveolar-soft-part-sarcoma

FDA grants approval to atezolizumab for alveolar soft part ... 1. ORR was 24% (95% CI: 13, 39). Of the 12 patients who experienced an objective response, 67% had a DOR of 6 months or more, and 42% had a DOR ...

4. esmoopen.com esmoopen.com/article/S2059-7029(23)01286-3/fulltext

Efficacy of immune checkpoint inhibitors in alveolar soft- ... The 12-month and 24-month OS rates were 94% and 81%, respectively. Conclusions. This registry constitutes the largest available series of ASPS ...

5. 2minutemedicine.com 2minutemedicine.com/atezolizumab-is-a-potentially-effective-treatment-option-for-patients-with-alveolar-soft-part-sarcoma/

Atezolizumab is a potentially effective treatment option for ... 1. 37% of study patients had an objective response to treatment with atezolizumab. · 2. Median progression-free survival was 20.8 months.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37466080/

Atezolizumab as the First Systemic Therapy Approved for ... Atezolizumab appears to be a viable treatment option in ASPS demonstrating clinical efficacy and a manageable toxicity profile. Conclusions: ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9730233/

Clinical features and therapeutic outcomes of alveolar soft ... The 5-year survival rate of stage IV ASPS patients was approximately 50%-60% in recent research (5, 17). Thirty years ago, a same rate of 5-year ...