OncoMatch/Clinical Trials/NCT06843551
The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation
Is NCT06843551 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Botensilimab and Balstilimab for metastatic pancreatic ductal adenocarcinoma.
Treatment: Botensilimab · Balstilimab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Biomarker criteria
Required: MSH2 microsatellite stable
Microsatellite stable (MSS) disease by pathologic assessment.
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Treatment with chemotherapy or targeted therapy within 2 weeks prior to initiating EMPIRE treatment.
Cannot have received: targeted therapy
Treatment with chemotherapy or targeted therapy within 2 weeks prior to initiating EMPIRE treatment.
Cannot have received: external beam radiation therapy to the liver
Previous external beam radiation therapy to the liver
Cannot have received: radioisotope therapy directed to the liver
radioisotope therapy directed to the liver
Cannot have received: liver embolization
any liver embolization
Lab requirements
Blood counts
ANC ≥1,000 cells/μL; WBC ≥2,000 cells/μL; platelets ≥75,000/μL; hemoglobin ≥8.0 g/dL; absolute lymphocyte count (ALC) ≥1000 cells/μL at baseline
Kidney function
creatinine clearance ≥40 mL/min
Liver function
serum total bilirubin ≤ 1.5x ULN; AST and ALT ≤3x ULN (or ≤5x ULN in patients with liver metastases); international normalized ratio or prothrombin time ≤1.5x ULN; activated partial thromboplastin time ≤2.5x ULN
Cardiac function
QTcF ≤ 480 ms
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 ≤ 1.5x ULN; AST and ALT ≤3x ULN (or ≤5x ULN in patients with liver metastases); international normalized ratio or prothrombin time ≤1.5x ULN; activated partial thromboplastin time ≤2.5x ULN; absolute lymphocyte count (ALC) ≥1000 cells/μL at baseline; QTcF ≤ 480 ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Miami · Miami, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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