50
Participants
Start Date
September 9, 2025
Primary Completion Date
September 30, 2030
Study Completion Date
September 30, 2030
5-Fluorouracil
Participants will be administered 2400 mg/m\^2 of 5-Fluorouracil via continuous intravenous infusion over a 46-hour period beginning on Day 1 of each two-week cycle of standard of care (SOC) modified Folfirinox combination therapy.
Oxaliplatin
Participants will be administered 85 mg/m\^2 of Oxaliplatin via intravenous infusion beginning on Day 1 of each two-week cycle of standard of care (SOC) modified Folfirinox combination therapy.
Leucovorin
Participants will be administered 400 mg/m\^2 of Leucovorin via intravenous infusion beginning on Day 1 of each two-week cycle of standard of care (SOC) modified Folfirinox combination therapy.
Irinotecan
Participants will be administered 150 mg/m\^2 of Irinotecan via intravenous infusion beginning on Day 1 of each two-week cycle of standard of care (SOC) modified Folfirinox combination therapy.
Gemcitabine
Participants will be administered 1000 mg/m\^2 of Gemcitabine standard of care (SOC) via intravenous infusion on days 1, 8 and 15 of each four-week treatment cycle.
Nab Paclitaxel
Participants will be administered 125 mg/m\^2 of Nab Paclitaxel standard of care (SOC) by intravenous infusion on days 1, 8 and 15 of each four-week treatment cycle.
Circulating Tumor Deoxyribonucleic acid (ctDNA) Assay
"ctDNA will be measured in participants in person via blood samples during Screening/Baseline and at the following intervals during treatment and follow-up:~* Every weeks 2 beginning at weeks 2, 4, 6 and 8 of standard of care therapy.~* Every 4 weeks beginning at week 10 of standard of care therapy until disease progression.~ctDNA will be measured to obtain participant tumor methylation scores (TMS)."
RECRUITING
University of Miami, Miami
Collaborators (1)
National Cancer Institute (NCI)
NIH
BillionToOne, Inc
UNKNOWN
University of Miami
OTHER