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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
2026-05-08
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 (3)
Profound Research LLC at Cancer and Leukemia Center
Troy, Michigan, United States
GenesisCare North Shore (Oncology)
St Leonards, New South Wales, Australia
Icon Cancer Centre Chermside
Chermside, Queensland, Australia