RecruitingPhase 2NCT06843551

The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation

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

Sponsor

Benjamin Spieler

Enrollment

20 participants

Start Date

Jun 18, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Pancreatic Cancer Metastatic Pancreatic Ductal Adenocarcinoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of immunotherapy (drugs that activate your immune system to fight cancer) and radiation therapy for people with pancreatic cancer that has spread (metastatic), to see if this approach can extend survival beyond what standard chemotherapy offers. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of pancreatic ductal adenocarcinoma - Your cancer is microsatellite stable (a specific lab result your doctor can check) - Your cancer has measurable tumors on imaging - You have already tried at least one prior treatment **You may NOT be eligible if...** - You are currently receiving other immunotherapy, chemotherapy, or immunosuppressive drugs - You have significant autoimmune disease or organ dysfunction - You have active brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic Body Radiation Therapy

The radiation therapy (RT) prescription biologically effective dose (BED10) goal for tumor (α/β=10) aims to achieve at least BED10= 60 Gy for a single fraction plan and at least BED10=100 Gy for a multi-fraction plan. This equates to a prescription dose of at least 20 Gy in a single fraction, 42 Gy over 3 fractions, 50 Gy over 5 fractions, and 62 Gy over 10 fractions. Radiation therapy must be completed for up to 10 daily treatments within a 15-day course.

DRUGBotensilimab

Participants will be receive 75mg of Botensilimab immunotherapy administered via intravenous infusion, every six weeks for up to 4 doses, about 24 weeks. Botensilimab therapy will begin no later than seven (7) days after completion of radiation therapy.

DRUGBalstilimab

Participants will receive 240mg of Balstilimab immunotherapy, administered via intravenous infusion, every 2 weeks for up to one (1) year. Balstilimab therapy will begin no later than seven (7) days after completion of radiation therapy.

Locations(1)

University of Miami

Miami, Florida, United States

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NCT06843551

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