This study is investigating the efficacy of the combination of Braftovi® capsules (active ingredient: encorafenib) and Erbitux® or an equivalent drug (biosimilar) (active ingredient: cetuximab) in colorectal cancer with metastases. The data obtained in this study should help to gain experience with these approved drugs under routine conditions.
Aim of the study
This study is investigating the efficacy of the combination of Braftovi® capsules (active ingredient: encorafenib) and Erbitux® or an equivalent drug (biosimilar) (active ingredient: cetuximab) in colorectal cancer with metastases. The data obtained in this study should help to gain experience with these approved drugs under routine conditions.
Who can take part?
Patients with metastatic colorectal cancer who have previously received a maximum of two systemic tumor therapies can participate in this study. Systemic means that the drug is introduced into the bloodstream and thus affects the entire body (e.g. chemotherapy). In addition, the colorectal cancer must be positive for the BRAFvsooE mutation. This is a change in the genetic material of the cancer cells that accelerates the growth of the tumor.
Procedure
Your participation lasts a minimum of 12 months and a maximum of 49 months (= total observation period). The study is scheduled to end in 2026. In line with the clinical routine, visits to the doctor take place approximately every two months in the first year and every three months thereafter. At these routine appointments, data is collected in a standardized form about your state of health, employment status, your colorectal cancer as well as cancers within your family, previous and current illnesses, current and subsequent treatments, concomitant treatments, results of blood and tumour tests. In addition, your doctor will ask you to complete questionnaires on your quality of life and satisfaction with the treatment at the start of treatment, during treatment and at the end of treatment. This takes about 10 to 20 minutes in each case.
You will be asked to complete standardized questionnaires: once before the start of your treatment, every two months during the course of your treatment within the first year and every three months thereafter, as well as at the end of your treatment. Questionnaires before the start of treatment and at the end of treatment will be handed out by the trial center staff. All other questionnaires will be sent to you directly by post.
Compensation
Original study name
Encorafenib and cetuximab in patients with metastatic colorectal cancer (CRC) with a BRAFvsooE mutation: a multicenter, national, prospective, non-interventional, long-term study in Switzerland. BERING-CRC
BASEC number
2022-00647
Sponsors