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

Part of paid clinical trials in Miami, Florida.

Sponsor
Benjamin Spieler
Study ID
NCT06843551
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Pancreatic Cancer
  • Metastatic Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Stereotactic Body Radiation Therapy — RADIATION
    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.
  • Botensilimab — DRUG
    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.
  • Balstilimab — DRUG
    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 Details

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.

Key Dates

Start date
Jun 18, 2025
Status verified
Aug 2025
Primary completion
Aug 1, 2030
Completion
Aug 1, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Radiation, Botensilimab Combined with Balstilimab Treatment Group
    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.

Primary Outcome Measure

Clinical Benefit Rate (CBR) [ Time Frame: Up to 15 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Benjamin Spieler, MD
[email protected]
305-243-4229
Benjamin Spieler, MD (PRINCIPAL_INVESTIGATOR)
Peter Hosein, MD (PRINCIPAL_INVESTIGATOR)
Ivaylo Mihaylov, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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