Actively Recruiting
The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation
Led by Benjamin Spieler · Updated on 2025-08-14
20
Participants Needed
1
Research Sites
267 weeks
Total Duration
On this page
Sponsors
B
Benjamin Spieler
Lead Sponsor
A
Agenus Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Confirmed diagnosis of pancreatic ductal adenocarcinoma by histology or cytology
- Microsatellite stable (MSS) disease confirmed by pathology
- Measurable disease as defined by RECIST 1.1 criteria
- Disease progression after at least one line of systemic therapy
- No concurrent treatment with interleukin-2, interferon, non-study immunotherapy, cytotoxic chemotherapy, immunosuppressive agents, other investigational therapies, or chronic systemic corticosteroids
- No known infection with HIV or active Hepatitis B infection
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
- Required laboratory values within 4 weeks prior to treatment including adequate neutrophil count, white blood count, platelets, hemoglobin, creatinine clearance, liver function tests, coagulation times, and lymphocyte count
- At least one lesion suitable for pre-treatment biopsy that has not been previously irradiated
- Liver tumor burden less than or equal to 25% of total liver volume
- Women of childbearing potential must have a negative serum pregnancy test within 7 days before starting treatment
- Male and female patients of reproductive potential must use effective contraception or abstain from sexual activity during the study and for at least 6 months after last dose of study drugs
You will not qualify if you...
- Liver tumor burden greater than 25% of total liver volume
- Active, untreated central nervous system metastases
- Active autoimmune disease or history requiring systemic treatment within 2 years
- Use of systemic corticosteroids greater than 10 mg prednisone equivalent daily within 14 days or other immunosuppressive drugs within 30 days prior to randomization
- Previous external beam radiation therapy or radioisotope therapy to the liver or liver embolization
- Clinically significant ascites requiring paracentesis within 4 weeks or history of liver failure
- Partial or complete bowel obstruction within 3 months or signs of impending obstruction
- Active cardiovascular disease including recent stroke, heart attack, unstable angina, severe heart failure, or uncontrolled arrhythmia
- QTcF interval greater than 480 ms
- Prior allogeneic organ transplantation
- Chemotherapy or targeted therapy within 2 weeks before starting study treatment
- Persistent grade 2 or higher adverse events from prior therapy (except neuropathy)
- Known additional malignancy requiring active treatment
- History of non-infectious pneumonitis
- Active infection requiring antibiotics
- Live vaccine within 30 days before treatment
- SARS-CoV-2 vaccine or booster less than 7 days before first cycle day 1
- History of severe hypersensitivity to monoclonal antibodies
- Impaired decision-making capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
B
Benjamin Spieler, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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