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Program Status Clinical trial’s patient recruitment status
Phase Phase of the clinical trial that is recruiting (I, II, or III)
Immunotherapy-centered Trial A flag to indicate whether the trial is an immunotherapy trial
Prior Immunotherapy Allowed Whether the clinical trial is open to patients who have received prior immunotherapy
CRC-directed Trial A flag to indicate whether the trial is specifically targeting colon cancer, rectal cancer, or colorectal cancer patients
Drugs Therapeutics used in the clinical trial
Tags
Comments
Phase III BREAKWATER trial. Only for patients with BRAF V600E–mutated, stage IV (metastatic) CRC, who are about to the receive their FIRST LINE of treatment, in the metastatic setting. Trial compares: 1. encorafenib (Braftovi) plus cetuximab (Erbitux) vs. 2. encorafenib (Braftovi) plus cetuximab (Erbitux) plus standard-of-care (SOC) chemotherapy vs. 3. chemotherapy alone
Contacts
Inclusion Criteria
Inclusion Criteria:
Safety Lead-In = Male/female ≥ 18 years old Phase 3 and Cohort 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: 0-1 regimens for Safety Lead In; none for Phase 3 and Cohort 3. (Note: Prior adjuvant or neoadjuvant therapy considered metastatic treatment if relapse/metastasis < 6 month from end of adj/neoadjuvant treatment ) Measurable disease (Phase 3 and Cohort 3)/ Measurable or evaluable disease (Safety Lead-in) ECOG PS 0-1 Adequate organ function
Exclusion Criteria
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
NCT ID Trial ID number from clinicaltrials.gov or other database
Date Trial Added Date on which the clinical trial was added to the clinicaltrials.gov website
Updated Date Date on which the clinical trial was updated on the clinicaltrials.gov website