SATURN-STS: Phase II Study of Neoadjuvant Atezolizumab With Doxorubicin, Concurrent Atezolizumab With Pre-operative Radiation Therapy and Adjuvant Atezolizumab in Patients With High-risk Surgically Resectable Extremity and Truncal Soft Tissue Sarcoma

NCT07049848 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2025-0511NCI-2025-04724
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to look at the effectiveness of giving a combination of chemotherapy, immunotherapy, radiation therapy, and surgery to treat soft tissue sarcomas that can be removed by surgery. Researchers want to find out if this treatment combination can extend the time it takes for the disease to relapse (come back after treatment). The safety of this treatment combination will also be studied.

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (1)

Phase II Treatment with Neo-Adju Chemo/Radiation/Surgery/Adju Chemo

EXPERIMENTAL

Participants will recived treatment on an outpatient basis

Drug: Atezolizumab; Drug: Doxorubicin Hydrochloride

Interventions

Atezolizumab DRUG

Given by IV

Phase II Treatment with Neo-Adju Chemo/Radiation/Surgery/Adju Chemo

Doxorubicin Hydrochloride DRUG

Given by IV

Phase II Treatment with Neo-Adju Chemo/Radiation/Surgery/Adju Chemo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects (Age ≥18 years) with treatment-naïve de novo or locally recurrent soft tissue sarcomas of the extremity or superficial trunk
• Histological diagnosis of grade 2 or grade 3 undifferentiated pleomorphic sarcoma (UPS), myxofibrosarcoma (MFS), de-differentiated/pleomorphic liposarcoma (DDLPS), unclassified sarcoma, and leiomyosarcoma. Pathologic terms for the "unclassified sarcoma" histology may include pleomorphic undifferentiated sarcoma, unclassified spindle cell sarcoma, spindle cell sarcoma not otherwise specified, pleomorphic spindle cell sarcoma, or pleomorphic fibroblastic sarcoma.
• Patient must have recent imaging (CT or MRI, as appropriate) within 8 weeks of trial enrollment demonstrating measurable disease, defined as at least one lesion that can be ccurately measured in at least one dimension (longest diameter to be recorded) as \>5 cm.
• Patients must have disease determined to be surgically resectable and candidates for upfront surgery as agreed upon by a multidisciplinary consensus (Surgical Oncology, Medical Oncology, Radiation Oncology) after presentation at sarcoma multidisciplinary conference. Resectable tumors are defined as having no significant vascular, neural, or bony involvement. Only cases where a complete surgical resection can safely be achieved are defined as resectable.
• Patients must have life expectancy \> 6 months.
• ECOG performance status ≤2 (Karnofsky ≥60%)
• For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
• Patients must have adequate organ and marrow function as defined below:
• absolute neutrophil count ≥1,000/mcL platelets ≥100,000/mcL total bilirubin ≤ institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN creatinine ≤ eGFR ≥40 ml/min
• Negative HIV test at screening, with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥ 200/L, and have an undetectable viral load
• Negative hepatitis B surface antigen (HBsAg) test at screening (if relevant)
• Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening (if relevant)
• a. The HCV RNA test must be performed for patients who have a positive HCV antibody test.
• Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
• The effects of Atezolizumab on the developing human fetus are unknown. For this reason and because doxorubicin as used in this trial is known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy #

You may not qualify if:

• Disease that is considered surgically unresectable, including, but not limited to significant vascular, neural, or bone involvement, and in cases where a complete surgical resection cannot be safely performed.
• Prior treatment with radiotherapy to the site of the sarcoma (re-irradiation or radiationinduced sarcomas are not allowed on this study)
• Active concurrent second malignancy within 2 years of trial enrollment. Note: patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Examples include non-melanomatous skin cancer, in situ carcinoma, or low-risk prostate cancer.
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
• Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug within 8 weeks of trial enrollment.
• Prior or concurrent immunotherapy, including treatment with an anti-PD-1, anti-PD-L1, antiPD-L2, or anti-CTLA-4 antibody; tumor vaccines; interferon, or interleukins.
• Recent stroke or thromboembolic event (within 6 months) requiring anticoagulation that cannot be interrupted. Non- life Threating deep venous thrombosis on stable anticoagulant within 6 months is allowed.
• Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
• Subjects with active, known or suspected autoimmune disease including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis.
• a. Patients with a history of autoimmune-related hypothyroidism who are on thyroidreplacement hormone are eligible for the study.
• Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
• Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:
• Rash must cover 10% of body surface area
• Disease is well controlled at baseline and requires only low-potency topical corticosteroids
• There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Sarcoma

Interventions

atezolizumab; Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Ahsan S Farooqi, MD, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahsan S Farooqi, MD, PHD

CONTACT

(713) 792-6453; afarooqi@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (1)