RecruitingRecruiting
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)
NCT07549412 · EMD Serono
In plain English
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Official title
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)
About this study
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 criteria
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 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
Study design
Enrollment target: 1020 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-05-06
Estimated completion: 2029-10-16
Last updated: 2026-06-16
Interventions
Drug: Precemtabart tocentecanDrug: BevacizumabDrug: Trifluridine/Tipiracil (FTD-TPI)
Primary outcomes
- • Arm 1, 2 and 3: Overall Survival (Time from date of randomization to death, assessed approximately up to average of 19 months)
Sponsor
EMD Serono Research & Development Institute, Inc. · industry
With: Merck KGaA, Darmstadt, Germany
Contacts & investigators
ContactUS Medical Information · contact · eMediUSA@emdserono.com · 888-275-7376
ContactCommunication Center · contact · service@emdgroup.com · +49 6151 72 5200
InvestigatorMedical Responsible · study_director, EMD Serono Research & Development Institute, Inc.
All locations (8)
Illinois CancerCare PCRecruiting
Peoria, Illinois, United States
Profound Research LLC at Cancer and Leukemia CenterRecruiting
Sterling Heights, Michigan, United States
Missouri Cancer Associates - 150518964Recruiting
Columbia, Missouri, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
Texas Oncology DFWRecruiting
Bedford, Texas, United States
Texas Oncology- San AntonioRecruiting
San Antonio, Texas, United States
GenesisCare North Shore (Oncology)Recruiting
St Leonards, New South Wales, Australia
Icon Cancer Centre ChermsideRecruiting
Chermside, Queensland, Australia