This phase III trial is evaluating whether targeted therapy, alone or in combination with chemotherapy, is more effective than standard care in patients with metastatic colorectal (bowel) cancer.
This trial is treating patients with colorectal (bowel) cancer.
This is a systemic therapy trial.
You may be able to join this trial if:
- Your cancer has spread to other parts of the body.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Trial Identifiers
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Scientific Title
AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE 3 STUDY OF FIRST-LINE ENCORAFENIB PLUS CETUXIMAB WITH OR WITHOUT CHEMOTHERAPY VERSUS STANDARD OF CARE THERAPY WITH A SAFETY LEAD-IN OF ENCORAFENIB AND CETUXIMAB PLUS CHEMOTHERAPY IN PARTICIPANTS WITH METASTATIC BRAF V600E-MUTANT COLORECTAL CANCER
Commercial Sponsor
Pfizer
Summary
Since Encorafenib (EC) has not previously been combined with chemotherapy, the tolerability and pharmacokinetics of EC in combination with mFOLFOX6 and FOLFIRI will be evaluated in a separate safety lead-in portion of the trial. This portion of the trial will be undertaken in order to identify which chemotherapy combination should be used in the second phase of the trial. Patients enrolled in the second phase of the trial will be randomised to receive Encorafenib plus Cetuximab alone or in combination with the chemotherapy selected in the first phase.
Recruiting Hospitals Read More