Purpose of this Study
We are doing this study to compare how safe and effective different drug combinations are for treating metastatic cancer.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with advanced or metastatic colorectal adenocarcinoma with KRAS p.G12C mutation
- Have not received any previous therapy for metastatic disease
For more information about who can join this study, please contact the study team at gi-oncology-cru@dm.duke.edu or 919-668-1861.
- Are diagnosed with advanced or metastatic colorectal adenocarcinoma with KRAS p.G12C mutation
- Have not received any previous therapy for metastatic disease
For more information about who can join this study, please contact the study team at gi-oncology-cru@dm.duke.edu or 919-668-1861.
What is Involved?
If you choose to join this study, you will:
- Get a random assignment (like a coin flip) to 1 of 2 groups
-- One group will get the study drug combination of sotorasib, panitumumab, and FOLFIRI
-- The other group will get FOLFIRI either on its own or with another drug called bevacizumab-awwb
- Have a tumor biopsy done, if necessary
- Have blood draws
- Have imaging scans (CT or MRI)
- Get a random assignment (like a coin flip) to 1 of 2 groups
-- One group will get the study drug combination of sotorasib, panitumumab, and FOLFIRI
-- The other group will get FOLFIRI either on its own or with another drug called bevacizumab-awwb
- Have a tumor biopsy done, if necessary
- Have blood draws
- Have imaging scans (CT or MRI)
Study Details
Full Title
Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib,
Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for
Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)
Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for
Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)
Principal Investigator
John
Strickler
Protocol Number
PRO00114638
NCT ID
NCT06252649
Phase
III
Enrollment Status
Open to Enrollment