Phase 3 Study Comparing IV Telisotuzumab Adizutecan Plus Bevacizumab to Standard Care with Oral TrifluridineTipiracil Plus IV Bevacizumab in Adults with Refractory Metastatic Colorectal Cancer

What this Trial Is About

Colorectal cancer CRC is the third most common cancer worldwide. This study evaluates the safety and disease activity changes of telisotuzumab adizutecan combined with bevacizumab compared to the standard of care treatment of trifluridine and tipiracil LONSURF plus bevacizumab. It focuses on adults with refractory metastatic colorectal cancer whose tumors overexpress c-Met. The trial is a global Phase 3 study involving approximately 700 participants. Participants are randomly assigned to one of two groups. One group receives intravenous telisotuzumab adizutecan plus intravenous bevacizumab, while the other group receives the standard care which includes oral trifluridine and tipiracil combined with intravenous bevacizumab. Both treatments continue for about 36 months. The study compares these two regimens to assess their effects on disease progression and adverse events. During the trial, participants attend regular visits at approved hospitals or clinics. Researchers monitor treatment effects through medical exams, blood tests, and questionnaires to track side effects and changes in disease activity. The main outcomes assessed include objective response and overall survival over 15 to 36 months, with additional measures such as progression-free survival and quality of life evaluations. Safety and treatment impact are closely followed throughout the study period.

A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer