Last updated 6 days ago
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)
1020 patients around the world
Available in Argentina, United States
EMD Serono Research & Development Institute, Inc.
5Research sites
1020Patients around the world
This study is for people with
Colorectal cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Centro de Investigaciones Médicas Tucumán
Recruiting
Centro Gutman
Recruiting
Investigaciones Clínicas Moleculares - ICM
Recruiting
Centro Oncológico de Excelencia - COE San Juan
Recruiting
Instituto de Oncología de Rosario - IOR
Recruiting
StudyPROCEADE-CRC-03
SponsorEMD Serono Research & Development Institute, Inc.
Study typeInterventional
Conditions
Colorectal cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07549412
