Metastatic Pancreatic Ductal AdenocarcinomaPhase 2EMPIRENCT06843551
The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation
A Phase 2 study testing Stereotactic Body Radiation Therapy, Botensilimab and Balstilimab in people with Metastatic Pancreatic Ductal Adenocarcinoma and Metastatic Pancreatic Cancer, run by Benjamin Spieler at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer
- What is being tested?
- Stereotactic Body Radiation Therapy, Botensilimab and Balstilimab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2025to 1 Aug 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
- Progression on ≥1 line of systemic therapy.
- 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.
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- No known infection with human immunodeficiency virus (HIV) or active infection with Hepatitis B.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Life expectancy ≥3 months.
- 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 ≤ 1.5 times the upper limit of normal (ULN)
- aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤3 × ULN (or ≤5 × ULN in patients with liver metastases)
- international normalized ratio or prothrombin time ≤1.5 × ULN
- activated partial thromboplastin time ≤2.5 × ULN
- absolute lymphocyte count (ALC) ≥1000 cells/μL at baseline
- At least 1 previously unirradiated lesion amenable to pre-treatment biopsy.
- No limit on overall numbers of lesions, but liver tumor burden ≤25% of total liver volume.
- Women of childbearing potential (WOCBP): negative serum pregnancy test (within 7 days prior to Day 1 of protocol therapy)
- Females of non-childbearing potential are defined as: i. ≥ 50 years of age and has not had menses for greater than 1 year ii. Amenorrheic for ≥ 2 years without a hysterectomy and bilateral oophorectomy and a follicle-stimulating hormone value in the postmenopausal range upon pre-study (screening) evaluation iii. Status is post-hysterectomy, bilateral oophorectomy, or tubal ligation.
- 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.
Who cannot join
- 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.
- Previous external beam radiation therapy to the liver or radioisotope therapy directed to the liver or any liver embolization.
- 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.
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- 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.
- 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.
- QT interval corrected using Fridericia's formula (QTcF) of > 480 ms.
- Prior allogeneic organ transplantation.
- Treatment with chemotherapy or targeted therapy within 2 weeks prior to initiating EMPIRE treatment.
- Persistent grade ≥2 adverse events (aEs) from prior therapy (except neuropathy).
- Known additional malignancy requiring active treatment.
- History of non-infectious pneumonitis.
- Active infection requiring antibiotic.
- Live vaccine within 30 days of protocol treatment.
- 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.
- History of severe hypersensitivity reaction to monoclonal antibody.
- Participants with impaired decision-making capacity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Benjamin Spieler, MD, 305-243-4229, bxs737@med.miami.edu
Benjamin Spieler, MD
About this study
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
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.
- Being tested
- Stereotactic Body Radiation Therapy, Botensilimab, Balstilimab
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation TherapyRadiation
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.
BotensilimabDrug
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.
BalstilimabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Radiation, Botensilimab Combined with Balstilimab Treatment Group | Experimental | Participants in this group will receive Stereotactic Body Radiation Therapy (SBRT), followed by Botensilimab immunotherapy (ImT) for up to 24 weeks, in combination with Balstilimab ImT for up to one year.
Total participation duration is up to five years. Receives: Radiation: Stereotactic Body Radiation Therapy; Drug: Botensilimab; Drug: Balstilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Rate (CBR)
The Clinical Benefit Rate (CBR) among participants will be reported. CBR is the number of participants achieving complete response (CR), partial response (PR) or stable disease after start of study therapy. Response will be assessed using Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) 1.1 criteria.
Measured: Up to 15 months
Secondary outcomes (4)
Objective Response Rate (ORR)
Objective response rate will be reported, based on best response according to Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) 1.1 criteria. Objective response (OR) is defined as the number of participants with confirmed complete response (CR) or confirmed partial response (PR) to study therapy.
Measured: Up to 15 months
Progression-Free Survival (PFS)
Progression-free survival (PFS) among participants will be reported. PFS is defined as the elapsed time in months since the start of radiation therapy until the first documentation of disease progression or death.
Measured: Up to 5 years
Overall Survival (OS)
Overall survival (OS) among participants will be reported. OS is defined as the elapsed time in months from the start of radiation therapy until death by any cause.
Measured: Up to 5 years
Number of Participants Experiencing Grade 3 or Higher Toxicities
The number of participants experiencing Grade 3 or higher toxicities will be reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start18 Jun 2025
- Primary completion1 Aug 2030 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benjamin Spieler
- Sponsor type
- University, hospital or other
- Collaborators
- Agenus Inc.
- Responsible party
- Sponsor-investigator, Benjamin Spieler, University of Miami
- Investigators
- Benjamin Spieler, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843551
- Sponsor's protocol ID
- 20240455
- Other IDs
- NCI-2025-04589
- Acronym
- EMPIRE
- Status last verified
- Aug 2026
- First submitted
- 20 Feb 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06843551
- Acronym / sponsor ID
- EMPIRE / 20240455
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Benjamin SpielerUniversity, hospital or other
- Collaborators
- Agenus Inc.
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 1 Aug 2030 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation, Botensilimab Combined with Balstilimab Treatment Group | Experimental | Radiation: Stereotactic Body Radiation Therapy, Drug: Botensilimab, Drug: BalstilimabParticipants in this group will receive Stereotactic Body Radiation Therapy (SBRT), followed by Botensilimab immunotherapy (ImT) for up to 24 weeks, in combination with Balstilimab ImT for up to one year. Total participation duration is up to five years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- ≥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.
- Progression on ≥1 line of systemic therapy.
Key exclusion criteria (19 listed)
- 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.
- Previous external beam radiation therapy to the liver or radioisotope therapy directed to the liver or any liver embolization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic Body Radiation TherapyThe 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. | Radiation | Radiation, Botensilimab Combined with Balstilimab Treatment Group |
| BotensilimabParticipants 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. | Drug | Radiation, Botensilimab Combined with Balstilimab Treatment Group |
| BalstilimabParticipants 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. | Drug | Radiation, Botensilimab Combined with Balstilimab Treatment Group |
Primary outcome
Clinical Benefit Rate (CBR)
Time frame: Up to 15 months
The Clinical Benefit Rate (CBR) among participants will be reported. CBR is the number of participants achieving complete response (CR), partial response (PR) or stable disease after start of study therapy. Response will be assessed using Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) 1.1 criteria.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 15 months
Progression-Free Survival (PFS)
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to 5 years
Number of Participants Experiencing Grade 3 or Higher Toxicities
Time frame: Up to 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Spieler, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Body Radiation Therapy, Botensilimab and Balstilimab in people with Metastatic Pancreatic Ductal Adenocarcinoma and Metastatic Pancreatic Cancer, run by Benjamin Spieler at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Spieler, MD (305-243-4229, bxs737@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Benefit Rate (CBR) (time frame: Up to 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.