Purpose of this Study
In this study, you will be placed into one of two treatment groups. One group will receive two medicines called telisotuzumab adizutecan and bevacizumab, given through a vein every three weeks. The other group will receive bevacizumab through a vein every two weeks and take a medicine called LONSURF by mouth on a repeating schedule. You will keep taking the study medicines as long as they are helping and side effects are manageable. Treatment is expected to last about one year. During treatment, you will have regular clinic visits and medical tests to check your health. After stopping the study medicines, you will have follow up visits at two weeks, one month, and about three months, and then the study team will check on you every three months to see how you are doing.
Who Can Participate?
Eligibility
People can join this study if they are 18 years old or older and have colon or rectal cancer that has spread to other parts of the body and cannot be removed with surgery. The cancer must be confirmed by doctors. People cannot join if they have already been treated with certain cancer medicines, including regorafenib, fruquintinib, or the combination of trifluridine and tipiracil.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is comparing a new medicine called telisotuzumab adizutecan to the usual treatment for people with colorectal cancer that has spread and did not respond to earlier treatments. The usual treatment uses two medicines called LONSURF and bevacizumab. Researchers want to see if the new medicine is safer and works better than the standard treatment at slowing the cancer and helping patients feel better.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
AndroMETa-CRC-560: An Open-Label, Randomized, Controlled, Global Phase 3 Study
Comparing Telisotuzumab Adizutecan (ABBV-400) plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with Refractory Metastatic Colorectal Cancer
Comparing Telisotuzumab Adizutecan (ABBV-400) plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with Refractory Metastatic Colorectal Cancer
Principal Investigator
Aman
Opneja
Protocol Number
PRO00120027
NCT ID
NCT07525206
Phase
III
Enrollment Status
Pending Open to Enrollment