New treatments tested in adults with colorectal cancer that has spread after earlier treatment
Compares precemtabart tocentecan with or without bevacizumab against standard treatment in colorectal cancer.
Plain-language title generated from the registry record
Registry 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)
Key facts
- Where
- Abilene, Arlington Heights, Austin, Bedford, Columbia, Fort Myers, Greenville, Lone Tree, Nashville, Newport News, Peoria, Roanoke, Saint Louis Park, San Antonio, San Francisco, Sioux Falls, Springfield, St. Petersburg, Sterling Heights, Tyler, West Palm Beach, and White Plains, United StatesSee the 22 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- How many different drug treatment plans (such as chemotherapy) have you had for cancer that has spread?
- Have you had another type of cancer in the past 3 years?
Source: NCT07549412, who can take part
Where in United States
- Texas Oncology, P.A. - Abilene - 300210366Abilene, United StatesTaking people
- Illinois Cancer SpecialistsArlington Heights, United StatesTaking people
- Texas Oncology South AustinAustin, United StatesTaking people
- Texas Oncology - DFWBedford, United StatesTaking people
- Missouri Cancer Associates - 150518964Columbia, United StatesTaking people
- Florida Cancer Specialists - BroadwayFort Myers, United StatesTaking people
- Prisma Health Cancer Institute, ITOR, CRUGreenville, United StatesTaking people
- Rocky Mountain Cancer Centers, LLP- AuroraLone Tree, United StatesTaking people
- SCRI Oncology PartnersNashville, United StatesTaking people
- Virginia Oncology AssociatesNewport News, United StatesTaking people
- Illinois CancerCare PCPeoria, United StatesTaking people
- Blue Ridge Cancer Care - 300202915Roanoke, United StatesTaking people
- Minnesota Oncology Hematology, P.A.Saint Louis Park, United StatesTaking people
- Texas Oncology - San AntonioSan Antonio, United StatesTaking people
- UCSF Mount Zion Medical CtrSan Francisco, United StatesTaking people
- Avera Cancer Institute - 300127370Sioux Falls, United StatesTaking people
- Springfield ClinicSpringfield, United StatesTaking people
- Florida Cancer Specialists - St. Petersburg BayfrontSt. Petersburg, United StatesTaking people
- Profound Research LLC at Cancer and Leukemia CenterSterling Heights, United StatesTaking people
- Texas Oncology, P.A. - TylerTyler, United StatesTaking people
- Florida Cancer Specialists East - FCS EAST - West Palm BeachWest Palm Beach, United StatesTaking people
- White Plains Hospital Medical and Wellness PRIMEWhite Plains, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- EMD Serono Research & Development Institute, Inc.
- Trial code
- NCT07549412EU 2025-524648-37-00
- Record updated
- 5 November 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: 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; Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization; Participant has a history of additional malignancy within 3 years before 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; Participants with known brain metastases; Other protocol defined exclusion criteria may apply.