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
Description
Brief Summary
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.
Detailed Description
The purpose of the study is to evaluate whether encorafenib plus cetuximab (EC), alone or in
combination with chemotherapy, can improve clinical outcomes relative to current standard
of-care chemotherapy in participants with previously untreated BRAF V600E-mutant mCRC. Since
encorafenib has not previously been combined with chemotherapy, the tolerability and PK of EC
in combination with mFOLFOX6 and in combination with FOLFIRI will be evaluated in separate
cohorts in the safety lead-in portion of the trial in order to identify which chemotherapy
combination is to be used in the Phase 3 portion of the study.
Phase
N/AInclusion and Exclusion Criteria
- - Safety Lead-In = Male/female ≥ 18 years old - Phase 3 and Cohort 3: Male/female ≥ 16 years old (where permitted locally) - Histologically or cytologically confirmed Stage IV CRC that contains BRAF V600E mutation - Prior systemic treatment in metastatic setting: 0-1 regimens for Safety Lead In; none
- (Note: Prior adjuvant or neoadjuvant therapy considered metastatic treatment if relapse/metastasis < 6 month from end of adj/neoadjuvant treatment ) - Measurable disease (Phase 3 and Cohort 3)/ Measurable or evaluable disease (Safety Lead-in) - ECOG PS 0-1 - Adequate organ function
- Tumors that are locally confirmed or unknown MSI-H or dMMR unless participant is ineligible to receive immune checkpoint inhibitors due to a pre-existing medical condition
- Active bacterial or viral infections in 2 weeks prior to starting dosing
- Symptomatic brain metastases
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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