Key Inclusion Criteria | Key Exclusion Criteria |
---|---|
1. Adult subjects at least 18 years old with treatment-naïve primary or locally recurrent DDLPS of the retroperitoneum or UPS of the trunk/extremity | 1. Active, known, or suspected autoimmune disease |
2. Disease determined to be surgically resectable and are candidates for upfront surgery as agreed upon by multidisciplinary consensus | 2. Known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome |
3. Recent imaging within 4Â weeks of trial enrollment, demonstrating measure disease as defined by RECIST 1.1 | 3. Any positive test results for hepatitis B or C virus indicating acute or chronic infection |
4. Must have at least 1 tumor amenable to serial biopsy in clinic or be willing to undergo serial biopsies through image-guided procedures during the neoadjuvant phase of the trial | 4. Condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. |
5. Must be medically fit to undergo surgery | 5. Prior intraabdominal surgery within 4Â weeks of trial enrollment |
6. Must be immunotherapy-naïve | 6. Prior chemotherapy for treatment of the sarcoma under consideration for resection or radiation therapy for sarcoma in the same area |
7. Patients who have received prior conventional chemotherapy for another malignancy are eligible after a 28Â day wash-out period | 7. Active concurrent second malignancy |
8. Patients must have organ/marrow function as defined below: | 8. Current use of anticoagulants at therapeutic levels |
 a. WBC > 3 K/uL, ANC > 1 K/uL | |
 b. hemoglobin > 9 g/dL | |
 c. platelets > 1000 K/mm3 | |
 d. serum creatinine < 2 mg/dL or creatinine clearance > 50 mL/min | |
 e. AST < 1.5 x upper limit of normal, ALT < 1.5 x upper limit of normal, bilirubin < 1.5 x upper limit of normal |