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

• Status: Recruiting
• Trial end date: 2026-11-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Collaborators: Merck KGaA, Darmstadt, Germany; Ono Pharmaceutical Co. Ltd
• Treatments: Bevacizumab; Capecitabine; Cetuximab; Fluorouracil; Irinotecan; Leucovorin; Oxaliplatin

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