Actively Recruiting
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)
Led by EMD Serono Research & Development Institute, Inc. · Updated on 2026-05-08
1020
Participants Needed
3
Research Sites
179 weeks
Total Duration
On this page
Sponsors
E
EMD Serono Research & Development Institute, Inc.
Lead Sponsor
M
Merck KGaA, Darmstadt, Germany
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with metastatic colorectal cancer confirmed by tissue diagnosis
- Participants who were intolerant to, refractory to, or progressed after standard systemic therapies
- No more than 2 previous systemic treatment regimens in the metastatic setting
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Ability to swallow oral tablets and comply with study evaluations
- Other protocol-defined inclusion criteria may apply
You will not qualify if you...
- Adverse events from previous therapies not recovered to less than Grade 1
- History of another cancer within 3 years before randomization
- Known brain metastases
- Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to randomization
- Ileus more than Grade 1, chronic inflammatory bowel disease, bowel obstruction, or chronic gastrointestinal disorders that affect drug absorption
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Profound Research LLC at Cancer and Leukemia Center
Troy, Michigan, United States, 48098
Actively Recruiting
2
GenesisCare North Shore (Oncology)
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
3
Icon Cancer Centre Chermside
Chermside, Queensland, Australia, 4032
Actively Recruiting
Research Team
U
US Medical Information
CONTACT
C
Communication Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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