20
Participants
Start Date
June 18, 2025
Primary Completion Date
August 1, 2030
Study Completion Date
August 1, 2030
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."
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.
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.
RECRUITING
University of Miami, Miami
Collaborators (1)
Agenus Inc.
INDUSTRY
Benjamin Spieler
OTHER