Miami, FLNCT06843551Now EnrollingIRB Ready

Metastatic Pancreatic Ductal Adenocarcinoma Clinical Trial in Miami, FL

Access cutting-edge metastatic pancreatic ductal adenocarcinoma treatment through this clinical trial at a research site in Miami. Study-provided care at no cost to qualified participants.

Sponsored by Benjamin Spieler

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Expert Care in Miami

Access metastatic pancreatic ductal adenocarcinoma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related metastatic pancreatic ductal adenocarcinoma treatment provided free

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Check if you qualify for this metastatic pancreatic ductal adenocarcinoma clinical trial in Miami, FL

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Why Participate?

  • No-Cost Study Care

  • Local to Miami

    Convenient for FL residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Miami site if eligible
  4. 4Begin participation

About This Metastatic Pancreatic Ductal Adenocarcinoma Study in Miami

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.

Sponsor: Benjamin Spieler

Who Can Participate

Inclusion 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 of systemic corticosteroids.
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 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.

Exclusion Criteria

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.
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. a. 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Miami?

Yes, this clinical trial (NCT06843551) has an active research site in Miami, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Metastatic Pancreatic Ductal Adenocarcinoma Treatment Options in Miami, FL

If you're searching for metastatic pancreatic ductal adenocarcinoma treatment options in Miami, FL, this clinical trial (NCT06843551) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Miami research site is actively enrolling participants for this clinical trial. You'll receive care from experienced metastatic pancreatic ductal adenocarcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all metastatic pancreatic ductal adenocarcinoma clinical trials near you to find additional studies recruiting in your area.

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