Full Title
Randomized Trial of Consolidation Targeted Adjuvant Therapy with Encorafenib and Cetuximab versus Usual Care for Patients with Stage II/III BRAF V600E Colon Cancer (A022004) (CIRB)Purpose
Researchers are comparing treatment with encorafenib and cetuximab to usual care (monitoring) after surgery and chemotherapy for colon cancer. The people in this study have stage 2B or stage 3 colon cancer. In addition, their cancer has mutations in a gene called BRAF. Doctors want to see if encorafenib and cetuximab lower the chance that the cancer will come back.
Encorafenib blocks some of the enzymes needed for cancer cell growth. Cetuximab binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep cancer cells from growing. Encorafenib and cetuximab after surgery and chemotherapy may better reduce the chance of cancer recurrence compared to the usual observation. Encorafenib is taken orally (by mouth) and cetuximab is given intravenously (by vein).
If you join this study, you will be randomly assigned to one of two groups after surgery and chemotherapy:
- Encorafenib and cetuximab, or
- Usual care (observation)
Who Can Join
To join this study, there are a few conditions. You must:
- Have stage 2B or 3 colon cancer with a BRAF V600E mutation.
- Have had at least 3 months of chemotherapy that was completed no more than 8 weeks before entering the study.
- Be able to walk and do routine activities for more than half the time you are awake.
- Be age 18 or older.
Contact
For more information or to see if you can join this study, please call Dr. Rona Yaeger’s office at 646-888-5109.