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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

BRAF V600E-mutant Colorectal Cancer Study of Encorafenib Taken With Cetuximab Plus or Minus Chemotherapy (BREAKWATER)

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
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

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