Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
EMD Serono Research & Development Institute, Inc. (Voir sur ClinicalTrials)
mai 2026
octobre 2029
09 octobre 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Michel DUCREUX | 19/10/2026 13:05:03 | Contacter | ||
Critères
Tous
- 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 Criteria:
- 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
- Participant has a history of additional malignancy within 3 years before
randomization
- Participants with known brain metastases
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 6 months prior to 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
- Other protocol defined exclusion criteria may apply