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)
Study on Medication for Cancer Spread from Colon or Rectum
Anita Turk, MD
Primary Investigator
Brief description of study
Primary objectivse:
To demonstrate improvement in OS with Precem-TcT as single agent compared to FTD-TPI plus bevacizumab. To demonstrate improvement in OS with Precem-TcT in combination with bevacizumab compared to FTD-TPI plus bevacizumab.
Secondary Objectives:
To evaluate OS of Precem-TcT as single agent and of Precem-TcT in combination with bevacizumab. To demonstrate improvement in PFS with Precem-TcT as single agent compared to FTD-TPI plus bevacizumab. To demonstrate improvement in PFS with Precem-TcT in combination with bevacizumab compared to FTD-TPI plus bevacizumab. To evaluate PFS of Precem-TcT as single agent and of Precem-TcT in combination with bevacizumab. To assess improvement in OR with Precem-TcT as single agent compared to FTD-TPI plus bevacizumab. To assess improvement in OR with Precem-TcT in combination with bevacizumab compared to FTD-TPI plus bevacizumab. To evaluate OR of Precem-TcT as single agent and of Precem-TcT in combination with bevacizumab. To evaluate DoR of Precem-TcT as single agent and of FTD-TPI plus bevacizumab. To evaluate DoR of Precem-TcT in combination with bevacizumab and of FTD-TPI plus bevacizumab. To evaluate DoR of Precem-TcT as single agent and of Precem-TcT in combination with bevacizumab. To evaluate the safety and tolerability with Precem-TcT as single agent compared to FTD-TPI plus bevacizumab. To evaluate the safety and tolerability with Precem-TcT in combination with bevacizumab compared to FTD-TPI plus bevacizumab. To evaluate the safety and tolerability with Precem-TcT as single agent compared to Precem-TcT in combination with bevacizumab.
- To characterize the PK profile of Precem-TcT (conjugated antibody and unconjugated payload) as single agent or in combination with bevacizumab.
- To characterize the immunogenicity of Precem-TcT.
- To evaluate quality of life with Precem-TcT as single agent or Precem-TcT in combination with bevacizumab compared to FTD-TPI plus bevacizumab using EORTC QLQ-C30 during the investigational treatment phase.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Metastatic Colorectal Cancer
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Age: 18 years - 100 years
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Gender: All
This study investigates the effects of an investigational medication for people with metastatic colorectal cancer. Metastatic colorectal cancer is a type of cancer that starts in the colon or rectum and spreads to other parts of the body. The purpose of this study is to compare the investigational medication alone and with another treatment to a standard treatment to see which is more effective in improving overall survival (OS) and progression-free survival (PFS).
Participants will be assigned to one of three study arms. Some will receive the investigational medication alone, while others will receive it with an additional treatment, or a standard treatment. Researchers will observe how the treatments affect the participants' cancer and gather information on the safety and side effects of the investigational medication. They will also monitor the participants' quality of life during the study.
- Who can participate: The study is for people with metastatic colorectal cancer who have already received treatment. Specific eligibility criteria were not provided.
- Study details: Participants will receive either the investigational medication alone, with another treatment, or a standard treatment. The study will compare the effects on cancer and evaluate safety and side effects. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
