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Compares treatment options for Metastatic Colorectal Cancer
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)
ClinicalTrials.gov ID: NCT07549412
What this study is testing
What is Precemtabart tocentecan?
Precemtabart tocentecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic colorectal cancer.
Also referred to as Precem-TcT.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory to...
- 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 may apply
You likely can't join if
- If Adverse Events related to previous therapies have not recovered to less than Grade 1 by National Cancer Institute - Common Terminology Criteria...
- 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...
- Other protocol defined exclusion criteria may apply
The study team makes the final eligibility decision.
Where it's taking place
- Peoria, Illinois, United States
- Sterling Heights, Michigan, United States
- Columbia, Missouri, United States
- Nashville, Tennessee, United States
- Bedford, Texas, United States
- San Antonio, Texas, United States
- St Leonards, New South Wales, Australia
- Chermside, Queensland, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Peoria, Illinois, United States; Sterling Heights, Michigan, United States; Columbia, Missouri, United States; Nashville, Tennessee, United States; Bedford, Texas, United States; San Antonio, Texas, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.