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

PHASE2RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

June 18, 2025

Primary Completion Date

August 1, 2030

Study Completion Date

August 1, 2030

Conditions
Metastatic Pancreatic Ductal AdenocarcinomaMetastatic Pancreatic Cancer
Interventions
RADIATION

Stereotactic Body Radiation Therapy

"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."

DRUG

Botensilimab

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.

DRUG

Balstilimab

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.

Trial Locations (1)

33136

RECRUITING

University of Miami, Miami

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Agenus Inc.

INDUSTRY

lead

Benjamin Spieler

OTHER