Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2025-11-20
50
Participants Needed
1
Research Sites
224 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult subjects aged 18 years or older with treatment-nafve de novo or locally recurrent soft tissue sarcomas of the extremity or superficial trunk
- Histological diagnosis of grade 2 or 3 undifferentiated pleomorphic sarcoma, myxofibrosarcoma, de-differentiated/pleomorphic liposarcoma, unclassified sarcoma, or leiomyosarcoma
- Recent imaging within 8 weeks showing at least one measurable lesion larger than 5 cm
- Tumor must be surgically resectable with no significant vascular, neural, or bony involvement, and complete surgical removal must be achievable
- Life expectancy greater than 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Stable anticoagulation regimen if receiving therapeutic anticoagulation
- Adequate organ and marrow function as defined by laboratory values
- Negative HIV test or stable HIV with CD4 count 200/L and undetectable viral load
- Negative hepatitis B surface antigen and hepatitis C virus antibody or RNA tests
- Cardiac function assessed as New York Heart Association Functional Classification class 2B or better
- Agreement to use adequate contraception prior to and during study participation for women of childbearing potential and men
- Ability to understand and willingness to sign informed consent
You will not qualify if you...
- Tumors considered surgically unresectable due to significant vascular, neural, or bone involvement
- Prior chemotherapy or targeted therapy for the current sarcoma
- Prior radiation therapy to the sarcoma site
- Presence of metastatic disease or regional lymph node involvement
- Active second malignancy within 2 years, except certain low-risk cancers
- History or evidence of pneumonitis or pulmonary fibrosis
- Receiving cancer therapy or investigational drugs within 8 weeks prior to enrollment
- Prior immunotherapy including checkpoint inhibitors or tumor vaccines
- Recent stroke or thromboembolic event requiring ongoing anticoagulation
- Serious or uncontrolled medical disorders that increase risk or interfere with study
- Active autoimmune diseases, except controlled hypothyroidism and type 1 diabetes on insulin
- Certain skin conditions unless well controlled and meeting specific criteria
- Significant cardiovascular disease within 3 months prior to study
- Current anti-viral treatment for hepatitis B
- Treatment with investigational, immunostimulatory, or immunosuppressive agents within specified time frames
- Known hypersensitivity to study drug components
- Positive tests for active hepatitis B or C infection
- Active tuberculosis
- Severe hypersensitivity to monoclonal antibodies
- Receipt of live vaccines within 30 days before study therapy
- Prior allogeneic stem cell or solid organ transplantation
- Other medical or psychiatric conditions that contraindicate study participation
- Pregnancy
- Weight over 400 lbs preventing radiation therapy
- Major surgery within 4 weeks prior or planned during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Ahsan S Farooqi, MD, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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