Research & Trial Information
Protocol #: A091401
Cancer Type: Sarcoma
- Patients must have histologically confirmed bone or soft tissue sarcoma by central pathology review.
- Measurable disease. Locally advanced/unresectable or metastatic disease.
- Prior Treatment• ≥ 1 prior systemic therapy for sarcoma, including adjuvant systemic therapy.
• No prior therapy with ipilimumab or nivolumab, or any agent targeting PD-1, PD-L1 or CTLA-4.
• No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation ≤ 28 days before study registration. No treatment with nitrosourea or mitomycin ≤ 42 days before study registration. For GIST, tyrosine kinase inhibitor can be continued for up to 3 days prior to initiation of study treatment.
• Patients should have resolution of any toxic effects of prior therapy
- No history of the following:• Active known or suspected autoimmune disease.
• Patients with HIV are eligible if the lymphocytes > 350 CD4+ cells and no detectable viral load
• Symptomatic, untreated, or uncontrolled brain metastases present.
• Active autoimmune colitis
• Autoimmune panhypopituitarism
• Autoimmune adrenal insufficiency
• Known active hepatitis B or C
- No systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration.
- Age ≥ 18 years.
- ECOG Performance Status 0 or 1.