A Study to Evaluate Encorafenib Plus Cetuximab with/without Chemotherapy to Treat Metastatic Colorectal Cancer


About this study

The purpose of this 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 metastatic colorectal cancer (mCRC).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

- Prior systemic treatment in metastatic setting

- SLI: 0-1 regimens

- Phase 3: None

- Prior adjuvant or neoadjuvant therapy considered metastatic treatment if
relapse/metastasis < 6 month from end of adj/neoadjuvant treatment

- 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

- Active bacterial or viral infections in 2 weeks prior to starting dosing

- Symptomatic brain metastases

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/7/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Christina Wu, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Joleen Hubbard, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


Publications are currently not available

Mayo Clinic Footer