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)
Key facts
- Where
- Ottawa, Toronto, and Vancouver, CanadaSee the 3 sites
- Phase
- Phase 3
Where in Canada
- The Ottawa Hospital Cancer CentreOttawa, CanadaTaking people
- University Health Network - Princess Margaret Cancer CentreToronto, CanadaTaking people
- BC Cancer - Vancouver - BC Cancer AgencyVancouver, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- EMD Serono Research & Development Institute, Inc.
- Trial code
- NCT07549412EU 2025-524648-37-00
- Record updated
- 5 November 2026
- Original description
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 trifluridine/tipiracil (FTD-TPI) plus bevacizumab.Read full original descriptionShow less
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)
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 trifluridine/tipiracil (FTD-TPI) plus bevacizumab.
Inclusion: Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory to, or progressed after standard systemic therapies and no more than 2 previous systemic treatment regimens in the metastatic setting; 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; Other protocol defined inclusion criteria may apply.
Exclusion: If Adverse Events related to previous therapies have not recovered to less than Grade 1 by National Cancer Institute - Common Terminology Criteria for Adverse Events version 6.0; Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization; Participant has a history of additional malignancy within 3 years before randomization; Participants with ileus of more than Grade 1, or chronic inflammatory bowel disease (example ulcerative colitis, Crohn's disease) and/or bowel obstruction, or participants with chronic gastrointestinal disorders that, in the Investigator's opinion, might significantly interfere with proper absorption of the study treatments; Participants with known brain metastases; Other protocol defined exclusion criteria may apply.