RECRUITING

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

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma Metastatic Pancreatic Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-01

Study Completion:2030-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06843551

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. ≥18 years old 2. Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma. 3. Microsatellite stable (MSS) disease by pathologic assessment. 4. Patients must have measurable disease as defined by RECIST 1.1. 5. Progression on ≥1 line of systemic therapy. 6. 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. 7. No known infection with human immunodeficiency virus (HIV) or active infection with Hepatitis B. 8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 9. Life expectancy ≥3 months. 10. Patients must have the following lab values obtained \<4 weeks prior to starting protocol treatment: 1. absolute neutrophil count (ANC) ≥1,000 cells/μL 2. white blood count (WBC) ≥2,000 cells/μL 3. platelets ≥75,000 per μL 4. hemoglobin ≥8.0 g/dL 5. creatinine clearance ≥40 mL/min) 6. serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN) 7. aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤3 × ULN (or ≤5 × ULN in patients with liver metastases) 8. international normalized ratio or prothrombin time ≤1.5 × ULN 9. activated partial thromboplastin time ≤2.5 × ULN 10. absolute lymphocyte count (ALC) ≥1000 cells/μL at baseline 11. At least 1 previously unirradiated lesion amenable to pre-treatment biopsy. 12. No limit on overall numbers of lesions, but liver tumor burden ≤25% of total liver volume. 13. Women of childbearing potential (WOCBP): negative serum pregnancy test (within 7 days prior to Day 1 of protocol therapy) 14. 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.	1. Liver tumor burden exceeding 25% of total liver volume. 2. Active, untreated central nervous system (CNS) metastases. 3. 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). 4. 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. 5. Previous external beam radiation therapy to the liver or radioisotope therapy directed to the liver or any liver embolization. 6. Clinically significant ascites requiring a paracentesis in the last 4 weeks, or clinically significant history of liver failure defined as any prior episode of hepatic encephalopathy and/or any prior history of an elevated serum ammonia level. 7. Partial or complete bowel obstruction within the last 3 months prior to study enrollment, signs/symptoms of bowel obstruction, or known radiologic evidence of impending obstruction. 8. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of study enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication. 9. Prior allogeneic organ transplantation. 10. Treatment with chemotherapy or targeted therapy within 2 weeks prior to initiating EMPIRE treatment. 11. Persistent grade ≥2 adverse events (aEs) from prior therapy (except neuropathy). 12. Known additional malignancy requiring active treatment. 13. History of non-infectious pneumonitis. 14. Active infection requiring antibiotic. 15. Live vaccine within 30 days of protocol treatment. 16. Severe acute respiratory syndrome (SARS) coronavirus 2 (CoV 2) (SARS-CoV-2) vaccine or booster \< 7 days before Cycle 1 Day 1 (C1D1). For vaccines requiring more than 1 dose, the full series should be completed prior to C1D1, when feasible. Booster shot not required but also must be administered \> 7 days from C1D1 or \> 7 days from future cycle on study. 17. History of severe hypersensitivity reaction to monoclonal antibody. 18. Participants with impaired decision-making capacity.

Inclusion Criteria

Exclusion Criteria

1. ≥18 years old
2. Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma.
3. Microsatellite stable (MSS) disease by pathologic assessment.
4. Patients must have measurable disease as defined by RECIST 1.1.
5. Progression on ≥1 line of systemic therapy.
6. 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.
7. No known infection with human immunodeficiency virus (HIV) or active infection with Hepatitis B.
8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
9. Life expectancy ≥3 months.
10. Patients must have the following lab values obtained \<4 weeks prior to starting protocol treatment:
1. absolute neutrophil count (ANC) ≥1,000 cells/μL
2. white blood count (WBC) ≥2,000 cells/μL
3. platelets ≥75,000 per μL
4. hemoglobin ≥8.0 g/dL
5. creatinine clearance ≥40 mL/min)
6. serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN)
7. aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤3 × ULN (or ≤5 × ULN in patients with liver metastases)
8. international normalized ratio or prothrombin time ≤1.5 × ULN
9. activated partial thromboplastin time ≤2.5 × ULN
10. absolute lymphocyte count (ALC) ≥1000 cells/μL at baseline
11. At least 1 previously unirradiated lesion amenable to pre-treatment biopsy.
12. No limit on overall numbers of lesions, but liver tumor burden ≤25% of total liver volume.
13. Women of childbearing potential (WOCBP): negative serum pregnancy test (within 7 days prior to Day 1 of protocol therapy)
14. 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.

1. Liver tumor burden exceeding 25% of total liver volume.
2. Active, untreated central nervous system (CNS) metastases.
3. 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).
4. 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.
5. Previous external beam radiation therapy to the liver or radioisotope therapy directed to the liver or any liver embolization.
6. Clinically significant ascites requiring a paracentesis in the last 4 weeks, or clinically significant history of liver failure defined as any prior episode of hepatic encephalopathy and/or any prior history of an elevated serum ammonia level.
7. Partial or complete bowel obstruction within the last 3 months prior to study enrollment, signs/symptoms of bowel obstruction, or known radiologic evidence of impending obstruction.
8. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of study enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.
9. Prior allogeneic organ transplantation.
10. Treatment with chemotherapy or targeted therapy within 2 weeks prior to initiating EMPIRE treatment.
11. Persistent grade ≥2 adverse events (aEs) from prior therapy (except neuropathy).
12. Known additional malignancy requiring active treatment.
13. History of non-infectious pneumonitis.
14. Active infection requiring antibiotic.
15. Live vaccine within 30 days of protocol treatment.
16. Severe acute respiratory syndrome (SARS) coronavirus 2 (CoV 2) (SARS-CoV-2) vaccine or booster \< 7 days before Cycle 1 Day 1 (C1D1). For vaccines requiring more than 1 dose, the full series should be completed prior to C1D1, when feasible. Booster shot not required but also must be administered \> 7 days from C1D1 or \> 7 days from future cycle on study.
17. History of severe hypersensitivity reaction to monoclonal antibody.
18. Participants with impaired decision-making capacity.

Contacts and Locations

Study Contact

Benjamin Spieler, MD

CONTACT

305-243-4229

bxs737@med.miami.edu

Principal Investigator

Benjamin Spieler, MD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: Benjamin Spieler

Benjamin Spieler, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-01

Study Completion Date2030-08-01

Study Record Updates

Study Start Date2025-08-01

Study Completion Date2030-08-01

Terms related to this study

Additional Relevant MeSH Terms

Metastatic Pancreatic Ductal Adenocarcinoma
Metastatic Pancreatic Cancer