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A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that: * has spread to other parts of the body (metastatic); * has a certain type of abnormal gene called "BRAF"; and * has not received prior treatment. Participants in this study will receive one of the following study treatments: * Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection into the vein) at the study clinic. * Encorafenib plus cetuximab with chemotherapy: These participants will receive encorafenib and cetuximab in the way described in the bullet above. Additionally, they will receive standard chemotherapy by IV infusion and oral treatment at home. * Chemotherapy alone: These participants will receive chemotherapy, the standard treatment for this condition, by IV infusion at the study clinics and oral treatment at home. This study is currently enrolling participants who will receive either encorafenib plus cetuximab with chemotherapy or chemotherapy alone. The study team will monitor how each participant responds to the study treatment for up to about 3 years.
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | PHASE3 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 831 |
| Start date | Mon Dec 21 2020 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Dec 28 2027 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Neoplasms
Interventions
- Encorafenib
- Cetuximab
- Oxaliplatin
- Irinotecan
- Leucovorin
- 5-FU
- Capecitabine
- Bevacizumab
Countries
Italy, Finland, Japan, Taiwan, Poland, South Korea, Denmark, New Zealand, Netherlands, Russia, Belgium, Sweden, Mexico, Bulgaria, Czechia, United States, South Africa, Slovakia, Norway, Argentina, Canada, Brazil, Spain, Ukraine, United Kingdom, Germany, Australia, China, India