Atezolizumab + Doxorubicin for Soft Tissue Sarcoma

Overseen By Ahsan S Farooqi, MD, PHD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Immunotherapy, Antivirals, Immunosuppressants, others

Disqualifiers: Unresectable disease, Metastatic disease, Autoimmune, 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: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment approach for surgically removable soft tissue sarcomas. Researchers combine chemotherapy (including doxorubicin), immunotherapy (including atezolizumab), radiation, and surgery to determine if this combination can delay cancer recurrence. They also aim to ensure the treatment's safety for participants. Individuals with specific types of soft tissue sarcoma, such as undifferentiated pleomorphic sarcoma or leiomyosarcoma, who have not yet received treatment, may be eligible to join. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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, it mentions that patients currently receiving cancer therapy or certain immunosuppressive medications may not be eligible. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this treatment combination is likely to be safe?

Initial findings suggest that the combination of atezolizumab and doxorubicin is generally well-tolerated in people with soft tissue sarcoma. Research shows that while patients experience side effects, these are mostly manageable. Common issues include fatigue and nausea, but serious side effects are less common.

Studies have shown that this treatment combination has been used before in advanced soft tissue sarcoma, and safety data indicates that patients can handle it reasonably well. These treatments are being tested because they have shown promise in helping patients. While some side effects are expected, researchers are working to ensure the treatment is as safe as possible.

Joining a trial is a personal decision, and discussing it with a healthcare provider can help clarify the risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about atezolizumab plus doxorubicin for soft tissue sarcoma because this combo offers a novel approach to treatment. Unlike the standard chemotherapy options, which primarily target and kill rapidly dividing cells, atezolizumab is an immunotherapy drug that works by bolstering the patient's immune system to recognize and attack cancer cells. This mechanism can potentially lead to more targeted cancer cell destruction with less collateral damage to healthy tissues. Additionally, the combination with doxorubicin, a well-known chemotherapy agent, aims to enhance the overall effectiveness against the tumor.

What evidence suggests that this treatment might be an effective treatment for soft tissue sarcoma?

Research shows that combining atezolizumab with doxorubicin may effectively treat soft tissue sarcomas. In this trial, participants will receive this combination treatment. Atezolizumab helps the immune system find and attack cancer cells. Past studies on similar treatments have shown improved survival rates over time, increasing from 22% in 1989 to 61% in 2018 for advanced cases. This combination might help shrink tumors and delay the disease's return. However, some patients might experience serious side effects. ^{2 5 6 7 8}

Who Is on the Research Team?

Ahsan S Farooqi, MD, PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with high-risk soft tissue sarcoma in the limbs or torso that can be surgically removed. Participants should not have had prior treatments for their sarcoma and must be fit enough to undergo chemotherapy, immunotherapy, radiation therapy, and surgery.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

My blood thinner medication dose has been stable.

Negative HIV test at screening

Exclusion Criteria

Unwillingness or inability to follow protocol procedures

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

Psychiatric illness/social situations limiting compliance with study requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy and Immunotherapy

Participants receive neoadjuvant doxorubicin chemotherapy with concurrent atezolizumab

6-8 weeks

Preoperative Radiation Therapy

Participants receive preoperative radiotherapy plus atezolizumab

4-6 weeks

Surgery

Participants undergo surgical resection of the tumor

1 week

Adjuvant Immunotherapy

Participants receive additional adjuvant atezolizumab

6-12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Atezolizumab
• Doxorubicin

Trial Overview The study tests a treatment combo of Atezolizumab (immunotherapy) with Doxorubicin (chemotherapy), alongside pre-operative radiation therapy followed by surgery. The aim is to see if this approach delays the cancer's return post-treatment and assess its overall safety.

How Is the Trial Designed?

Group I: Phase II Treatment with Neo-Adju Chemo/Radiation/Surgery/Adju Chemo Experimental Treatment 2 Interventions

Participants will recived treatment on an outpatient basis

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S104084282400088X

Patient-reported outcomes in randomized clinical trials of ... This systematic review evaluates reporting of patient-reported outcomes (PROs) within randomized clinical trials (RCTs) for advanced soft tissue sarcoma (STS) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11985850/

The outcomes and treatment strategies in metastatic soft ... Historical data showed that the rate of 5-year OS was about 22% in 1989, which increased to about 61% in 2018 in the metastatic setting (18).

3. withpower.com withpower.com/trial/phase-2-sarcoma-11-2025-aa535

Atezolizumab + Doxorubicin for Soft Tissue Sarcoma The goal of this clinical research study is to look at the effectiveness of giving a combination of chemotherapy, immunotherapy, radiation therapy, ...

4. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/soft-tissue-sarcoma

Soft Tissue Sarcoma Clinical Trials The drug atezolizumab unblocks the immune system. This allows immune cells to recognize and attack tumor cells. The drug could shrink cancer but could also have ...

5. ascopubs.org ascopubs.org/doi/10.1200/EDBK_432234

Immunotherapy in Sarcoma: Current Data and Promising ... Overall, grade 3-5 toxicity ranged from 7% to 76%. Combinations with chemotherapy led to substantial hematologic toxicity (absolute risk [AR], ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11337792/

PMC - PubMed Central Real-world efficacy, safety data and predictive clinical parameters for treatment outcomes in advanced soft tissue sarcoma treated with combined ...

7. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1504117/full

The outcomes and treatment strategies in metastatic soft ... This study was to investigate the efficacy and safety of immunotherapy-based therapy in metastatic STS.

8. academic.oup.com academic.oup.com/oncolo/article/30/10/oyaf337/8303965

Immune checkpoint inhibitors combined with tyrosine kinase ... The combination of ICIs and TKIs demonstrated promising efficacy, particularly in ASPS, with outcomes favorable to the historical benchmarks.