ABBV-400 + Bevacizumab vs LONSURF + Bevacizumab in Refractory Metastatic CRC (M24-560) - Clinical Trial

¿Cuál es el Propósito de este estudio?

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.

¿Cuál es la Condición que se está estudiando?

Refractory metastatic colorectal cancer

¿Quién puede participar en el Estudio?

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.

Grupo etario
Adultos

¿Qué Implica?

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.

Detalles del Estudio

Título Completo
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
Investigador Principal
Aman Opneja, MBBS
Especialista en oncología médica
Número de Protocolo
IRB: PRO00120027
NCT: NCT07525206
Fase
Phase III
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción
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Contribuya a Duke Health