drugset / Trial / NCT07549412
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)
Phase 3
Recruiting
1020 enrolled
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-05-06
- Primary completion
- 2029-10-16
- Completion
- 2029-10-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | — | Intravenous |
| Subject | Precemtabart tocentecan | Monoclonal antibody | — | Intravenous |
| Comparator | Trifluridine/Tipiracil | Unknown | — | Oral |