Breast Cancer Clinical Trial

A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer

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.

The study team will monitor how each participant responds to the study treatment for up to about 3 years.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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 < 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 condition
Active bacterial or viral infections in 2 weeks prior to starting dosing
Symptomatic brain metastases

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

765

Study ID:

NCT04607421

Recruitment Status:

Recruiting

Sponsor:

Pfizer

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Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

765

Study ID:

NCT04607421

Recruitment Status:

Recruiting

Sponsor:


Pfizer

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