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)

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.

Trial Details

NCT ID
NCT07549412
Phase
PHASE3
Sponsor
EMD Serono Research & Development Institute, Inc.
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • Precemtabart tocentecan
  • Bevacizumab
  • Trifluridine/Tipiracil (FTD-TPI)
Locations (sample)
  • Lone Tree, Colorado, United States|39.55171,-104.8863
  • Fort Myers, Florida, United States|26.62168,-81.84059
  • Arlington Heights, Illinois, United States|42.08836,-87.98063
  • Sterling Heights, Michigan, United States|42.58031,-83.0302
  • Saint Louis Park, Minnesota, United States|44.9483,-93.34801

Key Eligibility Criteria

  • Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory t…
  • Participants must have received and progressed on no more than 2 previous systemic treatment regimens in the metastatic setting
  • Eastern Cooperative Oncology Group (ECOG) performance status less than equal to 1
  • Participants must be able to swallow oral tablets, and to comply with the study requirements for all scheduled evaluations

For full eligibility, visit ClinicalTrials.gov.

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