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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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.
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
Treatment
VICCGI2085
NCT04607421

Eligibility

16 Years
BOTH
NO
Inclusion Criteria:

Safety Lead-In = Male/female 18 years old

Phase 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

SLI: 0-1 regimens

Phase 3: None

Prior adjuvant or neoadjuvant therapy considered metastatic treatment if relapse/metastasis
Measurable disease (Phase 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

To learn more about any of our clinical
trials, call 615-936-8422.