A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
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.
The study team will monitor how each participant responds to the study treatment for up to
about 3 years.
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.
The study team will monitor how each participant responds to the study treatment for up to
about 3 years.
Colon,
Rectal
Phase III
Both
Chemotherapy - cytotoxic,
Mol. targeted/Immunotherapy/Biologics
Bevacizumab,
CAPOX,
Cetuximab,
Encorafenib,
FOLFIRI (Leucovorin, 5-FU, Irinotecan),
FOLFOXIRI,
mFOLFOX6
Eng, Cathy
International
Vanderbilt University
04-06-2021
Eligibility
16 Years
BOTH
NO
Inclusion 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 for Phase 3 and Cohort 3. (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
Exclusion Criteria:
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
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 for Phase 3 and Cohort 3. (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
Exclusion Criteria:
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
