Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
Public ClinicalTrials.gov record NCT02928224. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib + binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study.
Study identification
- NCT ID
- NCT02928224
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 702 participants
Conditions and interventions
Interventions
- Encorafenib Drug
- Binimetinib Drug
- Cetuximab Drug
- Irinotecan Drug
- Folinic Acid Drug
- 5-Fluorouracil Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 13, 2016 (Actual)
- Primary completion
- Feb 11, 2019 (Actual)
- Completion
- Nov 10, 2022 (Actual)
- Last update posted
- Dec 21, 2023
2016 – 2022
United States locations
- U.S. sites
- 90
- U.S. states
- 22
- U.S. cities
- 48
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | — |
| Mayo Clinic | Phoenix | Arizona | 85054 | — |
| Mayo Clinic | Scottsdale | Arizona | 85259 | — |
| City of Hope (City of Hope National Medical Center, City of Hope Medical Center) | Duarte | California | 91010 | — |
| Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc. | Fountain Valley | California | 92708 | — |
| Keck Hospital of USC - Norris Healthcare Center (HC3) | Los Angeles | California | 90033 | — |
| Keck Hospital of USC | Los Angeles | California | 90033 | — |
| LAC+USC Medical Center | Los Angeles | California | 90033 | — |
| Norris Healthcare Center 3 (HC3) | Los Angeles | California | 90033 | — |
| USC Eye Institute | Los Angeles | California | 90033 | — |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | — |
| Harvard Eye Associates | Orange | California | 92868 | — |
| Rocky Mountain Lions Eye Institute | Aurora | Colorado | 80045 | — |
| University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora | Colorado | 80045 | — |
| University of Colorado Denver CTO (CTRC) | Aurora | Colorado | 80045 | — |
| University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) | Aurora | Colorado | 80045 | — |
| University of Colorado Hospital Inpatient Pavillion' | Aurora | Colorado | 80045 | — |
| Smilow Cancer Hospital at Yale - New Haven | New Haven | Connecticut | 06510 | — |
| Temple Medical Center | New Haven | Connecticut | 06510 | — |
| Yale University, Yale Cancer Center | New Haven | Connecticut | 06520 | — |
| Smilow Cancer Hospital Care Center at North Haven | North Haven | Connecticut | 06473 | — |
| The Lennar Foundation Medical Center | Coral Gables | Florida | 33146 | — |
| Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | — |
| Dr. Clayton Berger (opthalmology) | Fort Lauderdale | Florida | 33316 | — |
| Mehmet F. Hepgur, MD - Broward Health Medical Center | Fort Lauderdale | Florida | 33316 | — |
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | — |
| Sylvester Comprehensive Cancer Center/UMHC | Miami | Florida | 33136 | — |
| Sylvester at Kendall | Miami | Florida | 33176 | — |
| Illinois CancerCare- Bloomington | Bloomington | Illinois | 61704 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Illinois CancerCare- Galesburg | Galesburg | Illinois | 61401 | — |
| University of Chicago Comprehensive Cancer Center at Silver Cross Hospital | New Lenox | Illinois | 60451 | — |
| The University of Chicago Medicine Center for Advanced Care Orland Park | Orland Park | Illinois | 60462 | — |
| Illinois CancerCare- Ottawa | Ottawa | Illinois | 61350 | — |
| Illinois Cancer Care, PC | Peoria | Illinois | 61615 | — |
| Illinois Eye Center | Peoria | Illinois | 61615 | — |
| Carle Cancer Center | Urbana | Illinois | 61801 | — |
| Indiana University Health Hospital | Indianapolis | Indiana | 46202 | — |
| Indiana University Health Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| Investigational Drug Services IUHSCC | Indianapolis | Indiana | 46202 | — |
| Sidney &Lois Eskenazi Hospital | Indianapolis | Indiana | 46202 | — |
| IU Health Springmill | Indianapolis | Indiana | 46290 | — |
| Baptist Health Floyd Cancer Center | New Albany | Indiana | 47150 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| The University of Kansas Clinical Research Center | Fairway | Kansas | 66205 | — |
| The University of Kansas Hospital | Kansas City | Kansas | 66160 | — |
| KU Eye | Prairie Village | Kansas | 66208 | — |
| The University of Kansas Cancer Center and Medical Pavilion | Westwood | Kansas | 66205 | — |
| The University of Kansas Cancer Center, Investigational Drug Services | Westwood | Kansas | 66205 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21287 | — |
| The Investigational Drug Pharmacy (IDS) in the Sidney Kimmel Cancer Center at Johns Hopkins | Baltimore | Maryland | 21287 | — |
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Ophthalmic Consultants of Boston Inc | Boston | Massachusetts | 02114 | — |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | — |
| Dana-Farber Cancer Institute (DFCI) | Boston | Massachusetts | 02215 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Siteman Cancer Center - St Peters | City of Saint Peters | Missouri | 63376 | — |
| Siteman Cancer Center - West County | Creve Coeur | Missouri | 63141 | — |
| SSM Health Saint Louis University Hospital | St Louis | Missouri | 63104 | — |
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | — |
| Saint Louis University | St Louis | Missouri | 63110 | — |
| SSM Health Saint Louis University Hospital | St Louis | Missouri | 63110 | — |
| Washington University Infusion Center Pharmacy | St Louis | Missouri | 63110 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Siteman Cancer Center - South County | St Louis | Missouri | 63129 | — |
| Memorial Sloan Kettering: Basking Ridge | Basking Ridge | New Jersey | 07920 | — |
| Memorial Sloan Kettering: Commack | Commack | New York | 11725 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Memorial Sloan Kettering: Rockefeller Outpatient Pavilion | New York | New York | 10065 | — |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | — |
| Cleveland Clinic Taussig Cancer Institute | Cleveland | Ohio | 44195 | — |
| Casey Eye Institute-South Waterfront | Portland | Oregon | 97239 | — |
| OHSU Center for Health and Healing | Portland | Oregon | 97239 | — |
| OHSU Research Pharmacy Services | Portland | Oregon | 97239 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Henry-Joyce Cancer Clinic | Nashville | Tennessee | 37232 | — |
| Vanderbilt Eye Institute | Nashville | Tennessee | 37232 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030-4009 | — |
| Scott & White Clinic - Temple Pavilion | Temple | Texas | 76504 | — |
| Scott & White Medical Center - Temple | Temple | Texas | 76508 | — |
| Spokane Eye Clinic | Spokane | Washington | 99204 | — |
| Inland Imaging, LLC Holy Family Hospital | Spokane | Washington | 99208 | — |
| Medical Oncology Associates, PS DBA Summit Cancer Centers | Spokane | Washington | 99208 | — |
| Providence Holy Family Nuclear Medicine | Spokane | Washington | 99208 | — |
| Medical Oncology Associates, PS DBA Summit Cancer Centers | Spokane Valley | Washington | 99216 | — |
| University of Wisconsin Clinical Science Center | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 328 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02928224, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 21, 2023 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02928224 live on ClinicalTrials.gov.