The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation
Trial Parameters
Brief Summary
The purpose of this study is to assess if radiation therapy (which uses high-energy radiation to damage or destroy cancer cells) combined with immune checkpoint inhibitors (medications that helps the body recognize and attack cancer cells) will be beneficial for patients with metastatic pancreatic ductal adenocarcinoma.
Eligibility Criteria
Inclusion Criteria: 1. ≥18 years old 2. Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma. 3. Microsatellite stable (MSS) disease by pathologic assessment. 4. Patients must have measurable disease as defined by RECIST 1.1. 5. Progression on ≥1 line of systemic therapy. 6. No concomitant therapy with any of the following: interleukin (IL)-2, interferon, non study immunotherapy regimens, cytotoxic chemotherapy, immunosuppressive agents, other investigational therapies, and/or chronic use of systemic corticosteroids. 7. No known infection with human immunodeficiency virus (HIV) or active infection with Hepatitis B. 8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 9. Life expectancy ≥3 months. 10. Patients must have the following lab values obtained \<4 weeks prior to starting protocol treatment: 1. absolute neutrophil count (ANC) ≥1,000 cells/μL 2. white blood count (WBC) ≥2,000 cells/μL 3. platelets ≥75,000 per μL 4. hemoglobin