The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBenjamin Spieler
About this trial
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
Qualifiers
≥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.
Disqualifiers
Liver tumor burden exceeding 25% of total liver volume.
Active, untreated central nervous system (CNS) metastases.
Active autoimmune disease or history of autoimmune disease that required systemic treatment within 2 years of the start of study treatment (i.e., with use of disease-modifying agents or immunosuppressive drugs).
Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) within 14 days or another immunosuppressive medication within 30 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses (≤ 10 mg daily prednisone equivalent) are permitted in the absence of active autoimmune disease.
Trial design
Treatments tested in this trial
- Stereotactic Body Radiation Therapy
- Botensilimab
- Balstilimab
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
1University of Miami33136, MiamiFlorida, United States
Sponsors and collaborators
Benjamin Spieler
Lead sponsor
University of Miami
Sponsor institution
Agenus Inc.
Collaborator
Source ClinicalTrials.gov