Comparing Precem-TcT (with or without bevacizumab) versus trifluridine/tipiracil plus bevacizumab for people with previously treated metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3, randomized, multicenter trial comparing precemtabart tocentecan (Precem-TcT), given either alone or together with bevacizumab, against trifluridine/tipiracil (FTD‑TPI) plus bevacizumab in participants with metastatic colorectal cancer who have progressed after prior standard therapies. Participants must have received prior irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab and have ECOG performance status 0–1. The primary goal is to demonstrate an overall survival benefit for Precem-TcT-containing regimens; secondary endpoints include safety and other efficacy measures. The trial is sponsored by EMD Serono with collaboration from Merck KGaA and is open at sites in the United States and Australia.

Why it matters

Who can join: the full rules

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

Where it's running

• UCSF Mount Zion Medical Ctr
  San Francisco, California, United States Recruiting
• Rocky Mountain Cancer Centers, LLP- Aurora
  Lone Tree, Colorado, United States Recruiting
• Florida Cancer Specialists-Broadway
  Fort Myers, Florida, United States Recruiting
• Florida Cancer Specialists - St. Petersburg Bayfront
  St. Petersburg, Florida, United States Recruiting
• Florida Cancer Specialists East - FCS EAST - West Palm Beach
  West Palm Beach, Florida, United States Recruiting
• Illinois Cancer Specialists
  Arlington Heights, Illinois, United States Recruiting

+66 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: US Medical Information
• Email: eMediUSA@emdserono.com
• Phone: 888-275-7376

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.