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)
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- DrugPrecemtabart tocentecan
Precem-TcT, administered, once every 3 weeks intravenously, on Day 1 of each 21-day cycle.
- DrugBevacizumab
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.
- DrugTrifluridine/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 CenterTroy, Michigan
- GenesisCare North Shore (Oncology)St Leonards, New South Wales
- Icon Cancer Centre ChermsideChermside, Queensland