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New treatment option for Metastatic Pancreatic Ductal Adenocarcinoma
Official title The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation
ClinicalTrials.gov ID: NCT06843551
What this study is testing
What is Botensilimab?
Botensilimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic pancreatic ductal adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥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.
You likely can't join if
- 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...
- Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) within 14 days or...
- 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...
See the full eligibility criteria
- ≥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...
- 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) a. Females of non-childbearing potential are defined as: i. ≥ 50 years of age and has not had...
- 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...
- 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...
- 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...
- 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...
- 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 from C1D1 or \> 7 days from future cycle on study.
- History of severe hypersensitivity reaction to monoclonal antibody.
- Participants with impaired decision-making capacity.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.