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A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)
Sponsor: EMD Serono Research & Development Institute, Inc.
Summary
This study aims to address the unmet medical need of participants with metastatic colorectal cancer (mCRC) who have previously been treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, by demonstrating an overall survival prolongation with precemtabart tocentecan (Precem-TcT) as single agent or Precem-TcT in combination with bevacizumab compared to trifluoride/tipiracil (FTD-TPI) plus bevacizumab.
Official title: A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1020
Start Date
2026-05-06
Completion Date
2029-10-16
Last Updated
2026-07-24
Healthy Volunteers
No
Conditions
Interventions
Precemtabart tocentecan
Precem-TcT, administered, once every 3 weeks intravenously, on Day 1 of each 21-day cycle.
Bevacizumab
Bevacizumab, administered intravenously every 3 weeks on Day 1 of each 21-day cycle or every 2 weeks on Day 1 and Day 15 of each 28-day cycle.
Trifluridine/Tipiracil (FTD-TPI)
FTD-TPI, tablet, administered orally twice daily, on Days 1 to 5 and Days 8 to 12 of each 28-day cycle.
Locations (21)
Rocky Mountain Cancer Centers, LLP- Aurora
Lone Tree, Colorado, United States
Illinois Cancer Specialists
Arlington Heights, Illinois, United States
Illinois CancerCare PC
Peoria, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
Profound Research LLC at Cancer and Leukemia Center
Sterling Heights, Michigan, United States
Minnesota Oncology Hematology, P.A.
Saint Louis Park, Minnesota, United States
Missouri Cancer Associates - 150518964
Columbia, Missouri, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Texas Oncology, P.A. - Abilene - 300210366
Abilene, Texas, United States
Texas Oncology-South Austin
Austin, Texas, United States
Texas Oncology DFW
Bedford, Texas, United States
Texas Oncology- San Antonio
San Antonio, Texas, United States
Texas Oncology, P.A. - Tyler
Tyler, Texas, United States
Virginia Oncology Associates
Newport News, Virginia, United States
Blue Ridge Cancer Care - 300202915
Roanoke, Virginia, United States
GenesisCare North Shore (Oncology)
St Leonards, New South Wales, Australia
Icon Cancer Centre Chermside
Chermside, Queensland, Australia
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, Canada
National Cancer Center Hospital
Chūōku, Tokyo-To, Japan
Samsung Medical Center
Seoul, South Korea
China Medical University Hospital
Taichung, Taiwan