67
Participants
Start Date
August 24, 2023
Primary Completion Date
April 18, 2026
Study Completion Date
March 31, 2030
certepetide
LSTA1 3.2 mg/kg given as a slow IV push over 1 minute when standard treatment(s) are given
Durvalumab
1500 mg of durvalumab IV administered over 1 hour every 21 days for 8 cycles then every 28 days for additional cycles
Cisplatin
cisplatin 25 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
Gemcitabine
gemcitabine 1000 mg/m² IV administered over 30 minutes on day 1 and day 8 every 21 days for up to 8 cycles
FOLFOX regimen
"The following will be given every 14 days:~* oxaliplatin 85 mg/m² and l-folinic acid 200 mg/m² or d,l-folinic acid 400 mg/m² concurrently, as a 2-hour IV infusion~* fluorouracil (5-FU) 400 mg/m² will be given as an IV bolus over 5 minutes~* fluorouracil (5-FU) 2400 mg/m² will be administered over 46 hours (via home-infusion pump)"
Placebo
Placebo given as a slow IV push over 1 minute when standard treatment(s) are given
Northwell Health - Zuckerberg Cancer Center, Lake Success
Stony Brook Cancer Center, Stony Brook
Inova Schar Cancer Institute, Fairfax
FirstHealth of the Carolinas, Inc., Pinehurst
Spartanburg Medical Center, Spartanburg
Moffitt Cancer Center, Tampa
Vanderbilt University Medical Center, Nashville
Norton Cancer Institute, Downtown, Louisville
Norton Cancer Institute, Audubon, Louisville
University of Kentucky Medical Center, Lexington
Carl & Edyth Lindner Center for Research & Education at The Christ Hospital and The Christ Hospital Cancer Center, Cincinnati
Mayo Clinic Rochester, Rochester
Alliance for Multispecialty Research, Merriam
University of Kansas Cancer Center, Westwood
University of Texas Southwestern Medical Center, Dallas
The University of Texas MD Anderson Cancer Center, Houston
Mayo Clinic Arizona, Phoenix
Banner MD Anderson Cancer Center, Gilbert
University of Arizona Cancer Center, Tucson
Lead Sponsor
Lisata Therapeutics, Inc.
INDUSTRY