Clinical Trial

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)

Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 changes
notable Trial sites expanded: 21 -> 34 locations 2026-08-15
notable Trial sites expanded: 8 -> 21 locations 2026-07-25
notable Trial sites expanded: 3 -> 8 locations 2026-06-17
critical Recruitment opened 2026-05-09
notable Primary completion pushed: 2028-12-25 -> 2029-10-16 2026-05-09
Trial Details
NCT Number NCT07549412
Lead Sponsor EMD Serono Research & Development Institute, Inc.
Collaborators: Merck KGaA, Darmstadt, Germany
Conditions Metastatic Colorectal Cancer
Enrollment 1,020 participants
Start Date 2026-05-06
Primary Completion 2029-10-16 (estimated)
Study Completion 2029-10-16 (estimated)
Updated on ClinicalTrials.gov 2026-08-14