A Phase 2 Single Arm Trial of Stereotactic Body Radiation Therapy Followed by Dual Immune Checkpoint Inhibition for Patients With Metastatic Pancreatic Ductal Adenocarcinoma - The Miami EMPIRE Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation
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.
• ≥18 years old
• Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma.
• Microsatellite stable (MSS) disease by pathologic assessment.
• Patients must have measurable disease as defined by RECIST 1.1.
• Progression on ≥1 line of systemic therapy.
• 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.
• No known infection with human immunodeficiency virus (HIV) or active infection with Hepatitis B.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Life expectancy ≥3 months.
⁃ Patients must have the following lab values obtained \<4 weeks prior to starting protocol treatment:
∙ absolute neutrophil count (ANC) ≥1,000 cells/μL
‣ white blood count (WBC) ≥2,000 cells/μL
‣ platelets ≥75,000 per μL
‣ hemoglobin ≥8.0 g/dL
‣ creatinine clearance ≥40 mL/min)
‣ serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN)
‣ aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤3 × ULN (or ≤5 × ULN in patients with liver metastases)
‣ international normalized ratio or prothrombin time ≤1.5 × ULN
‣ activated partial thromboplastin time ≤2.5 × ULN
∙ absolute lymphocyte count (ALC) ≥1000 cells/μL at baseline
⁃ At least 1 previously unirradiated lesion amenable to pre-treatment biopsy.
⁃ No limit on overall numbers of lesions, but liver tumor burden ≤25% of total liver volume.
⁃ Women of childbearing potential (WOCBP): negative serum pregnancy test (within 7 days prior to Day 1 of protocol therapy)
⁃ a. Females of non-childbearing potential are defined as: i. ≥ 50 years of age and has not had menses for greater than 1 year ii. Amenorrheic for ≥ 2 years without a hysterectomy and bilateral oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation iii. Status is post-hysterectomy, bilateral oophorectomy, or tubal ligation.
⁃ Male and female patients of reproductive potential must use effective methods of contraception or abstain from sexual activity for the course of the study through at least 6 months after the last dose of balstilimab and/or botensilimab. See Section 4.11, Contraception.