ClinicalTrials.gov record
A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT05253651
Public ClinicalTrials.gov record NCT05253651. 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
An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable). Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either: * mFOLFOX6 alone, * mFOLFOX6 with bevacizumab, or * mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.
Study identification
- NCT ID
- NCT05253651
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 400 participants
Conditions and interventions
Conditions
Interventions
- tucatinib Drug
- trastuzumab Drug
- bevacizumab Drug
- cetuximab Drug
- oxaliplatin Drug
- leucovorin Drug
- levoleucovorin Drug
- 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 23, 2022
- Primary completion
- Dec 30, 2027
- Completion
- Jul 2, 2030
- Last update posted
- Jul 21, 2026
2022 – 2030
United States locations
- U.S. sites
- 132
- U.S. states
- 19
- U.S. cities
- 85
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Palo Verde Hematology Oncology | Glendale | Arizona | 85304 | Recruiting |
| Mayo Clinic Building - Phoenix | Phoenix | Arizona | 85054 | Recruiting |
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | Recruiting |
| Mayo Clinic | Scottsdale | Arizona | 85259 | Recruiting |
| Los Angeles Cancer Network - Anaheim | Anaheim | California | 92801 | Recruiting |
| Kaiser Permanente Anaheim Kraemer Medical Offices | Anaheim | California | 92806 | Active, not recruiting |
| Kaiser Permanente Baldwin Park Medical Center | Baldwin Park | California | 91706 | Active, not recruiting |
| Kaiser Permanente Bellflower Medical Offices | Bellflower | California | 90706 | Active, not recruiting |
| Kaiser Permanente Fontana Medical Center | Fontana | California | 92335 | Active, not recruiting |
| Los Angeles Cancer Network - Fountain Vally | Fountain Valley | California | 92708 | Recruiting |
| Los Angeles Cancer Network - Corporate Office | Glendale | California | 91204 | Recruiting |
| Los Angeles Hematology Oncology Medical Group | Glendale | California | 91204 | Recruiting |
| Los Angeles Hematology Oncology Medical Group | Glendale | California | 91206 | Recruiting |
| Kaiser Permanente South Bay Medical center | Harbor City | California | 90710 | Active, not recruiting |
| Kaiser Permanente Alton/Sand Canyon Medical Offices | Irvine | California | 92618 | Active, not recruiting |
| Los Angeles Hematology Oncology Medical Group | Los Angeles | California | 90017 | Recruiting |
| USC Norris Koreatown - Medical Oncology | Los Angeles | California | 90020 | Terminated |
| Kaiser Permanente Los Angeles Medical Offices | Los Angeles | California | 90027 | Active, not recruiting |
| Keck Hospital of USC | Los Angeles | California | 90033 | Terminated |
| Los Angeles General Medical Center | Los Angeles | California | 90033 | Terminated |
| University of Southern California | Los Angeles | California | 90033 | Terminated |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | Terminated |
| Kaiser Permanente West Los Angeles Medical Center | Los Angeles | California | 90034 | Active, not recruiting |
| USC Norris Oncology/Hematology - Newport Beach | Newport Beach | California | 92663 | Terminated |
| Kaiser Permanente Ontario Medical Center | Ontario | California | 91761 | Active, not recruiting |
| Kaiser Permanente Panorama City Medical Center | Panorama City | California | 91402 | Active, not recruiting |
| Keck Medical Center of USC Pasadena | Pasadena | California | 91105 | Terminated |
| Los Angeles Hematology Oncology Medical Group | Pasadena | California | 91105 | Recruiting |
| Kaiser Permanente Riverside Medical Center | Riverside | California | 92505 | Active, not recruiting |
| Kaiser Permanente San Diego Mission Road (Regulatory and Lab Supplies) | San Diego | California | 92108 | Active, not recruiting |
| Kaiser Permanente Zion Medical Center | San Diego | California | 92120 | Active, not recruiting |
| Kaiser Permanente San Marcos Medical Offices | San Marcos | California | 92078 | Active, not recruiting |
| Los Angeles Hematology Oncology Medical Group | Van Nuys | California | 91405 | Recruiting |
| Kaiser Permanente Woodland Hills Medical Center | Woodland Hills | California | 91367 | Active, not recruiting |
| Rocky Mountain Cancer Centers, LLP | Aurora | Colorado | 80012 | Recruiting |
| Rocky Mountain Cancer Centers, LLP | Boulder | Colorado | 80303 | Recruiting |
| Rocky Mountain Cancer Centers, LLP | Colorado Springs | Colorado | 80907 | Recruiting |
| Rocky Mountain Cancer Centers, LLP | Denver | Colorado | 80218 | Recruiting |
| Rocky Mountain Cancer Centers, LLP | Denver | Colorado | 80220 | Recruiting |
| Rocky Mountain Cancer Centers, LLP | Lakewood | Colorado | 80228 | Recruiting |
| Rocky Mountain Cancer Centers, LLP | Littleton | Colorado | 80120 | Recruiting |
| Rocky Mountain Cancer Centers, LLP | Lone Tree | Colorado | 80124 | Recruiting |
| Rocky Mountain Cancer Centers, LLP | Longmont | Colorado | 80504 | Recruiting |
| Rocky Mountain Cancer Centers, LLP | Pueblo | Colorado | 81003 | Recruiting |
| Rocky Mountain Cancer Centers, LLP | Thornton | Colorado | 80260 | Recruiting |
| Mount Sinai Medical Center Aventura ER | Aventura | Florida | 33180 | Recruiting |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | Recruiting |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | Recruiting |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | Recruiting |
| Emory University Hospital | Atlanta | Georgia | 30322 | Recruiting |
| Winship Cancer Institute | Atlanta | Georgia | 30322 | Recruiting |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30342 | Recruiting |
| Alliance for Multispecialty Research LLC. | Merriam | Kansas | 66204 | Terminated |
| Norton Cancer Institute - Downtown | Louisville | Kentucky | 40202 | Recruiting |
| Norton Cancer Institute, Downtown | Louisville | Kentucky | 40202 | Recruiting |
| Norton Hospital | Louisville | Kentucky | 40202 | Recruiting |
| Norton Audubon Hospital | Louisville | Kentucky | 40217 | Recruiting |
| Norton Cancer Institute, Audubon Hospital Campus | Louisville | Kentucky | 40217 | Recruiting |
| Norton Brownsboro Hospital | Louisville | Kentucky | 40241 | Recruiting |
| Norton Cancer Institute, Brownsboro Hospital Campus | Louisville | Kentucky | 40241 | Recruiting |
| Minnesota Oncology Hematology, PA | Burnsville | Minnesota | 55337 | Recruiting |
| Allina Health Cancer institute | Coon Rapids | Minnesota | 55433 | Recruiting |
| Minnesota Oncology Hematology, PA | Coon Rapids | Minnesota | 55433 | Recruiting |
| M Health Fairview Cancer Clinic-Edina | Edina | Minnesota | 55435 | Recruiting |
| Minnesota Oncology Hematology, PA | Edina | Minnesota | 55435 | Recruiting |
| Minnesota Oncology Hematology, PA | Fridley | Minnesota | 55432 | Recruiting |
| Minnesota Oncology Hematology, PA | Maple Grove | Minnesota | 55369 | Recruiting |
| M Health Fairview St. John's Hospital | Maplewood | Minnesota | 55109 | Recruiting |
| Minnesota Oncology Hematology, PA | Maplewood | Minnesota | 55109 | Recruiting |
| Allina Health Cancer Institute (Virginia Piper Cancer Institute) | Minneapolis | Minnesota | 55404 | Recruiting |
| Minnesota Oncology Hematology, PA | Minneapolis | Minnesota | 55404 | Recruiting |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | Recruiting |
| North Memorial Health Cancer Center | Robbinsdale | Minnesota | 55422 | Recruiting |
| Mayo Clinic Cancer Center Outpatient Pharmacy | Rochester | Minnesota | 55905 | Recruiting |
| Metro Minnesota Community Oncology Research Consortium | Saint Louis Park | Minnesota | 55416 | Recruiting |
| Park Nicollet Frauenshuh Cancer Center | Saint Louis Park | Minnesota | 55426 | Recruiting |
| Regulatory Location: MMCORC | Saint Louis Park | Minnesota | 55426 | Recruiting |
| Regions Hospital | Saint Paul | Minnesota | 55101 | Recruiting |
| Allina Health Cancer Institute-United(VPCI) | Saint Paul | Minnesota | 55102 | Recruiting |
| Minnesota Oncology Hematology, PA Cornerstone Medical Specialty Center | Woodbury | Minnesota | 55125 | Recruiting |
| MSK Basking Ridge | Basking Ridge | New Jersey | 07920 | Recruiting |
| MSK Monmouth | Middletown | New Jersey | 07748 | Recruiting |
| MSK Bergen | Montvale | New Jersey | 07645 | Recruiting |
| MSK Commack | Commack | New York | 11725 | Recruiting |
| MSK Westchester | Harrison | New York | 10604 | Recruiting |
| Rockefeller Outpatient Pavilion (53rd Street) | New York | New York | 10022 | Recruiting |
| Memorial Solan Kettering Cancer Center- Main Campus | New York | New York | 10065 | Recruiting |
| MSK Nassau | Uniondale | New York | 11553 | Recruiting |
| Duke University Hospital | Durham | North Carolina | 27710 | Recruiting |
| Duke University Medical Center, Duke Cancer Center | Durham | North Carolina | 27710 | Recruiting |
| Duke University Medical Center | Durham | North Carolina | 27710 | Recruiting |
| FirstHealth Cancer Center | Pinehurst | North Carolina | 28374 | Recruiting |
| FirstHealth Moore Regional Hospital | Pinehurst | North Carolina | 28374 | Recruiting |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | Terminated |
| Northwest Cancer Specialists, P.C | Happy Valley | Oregon | 97015 | Recruiting |
| Providence Cancer Institute Newberg Clinic | Newberg | Oregon | 97132 | Recruiting |
| Providence Cancer Institute Willamette Falls Clinic | Oregon City | Oregon | 97045 | Recruiting |
| Providence Cancer Institute Franz Clinic | Portland | Oregon | 97213 | Recruiting |
| Providence Portland Medical Center | Portland | Oregon | 97213 | Recruiting |
| Providence Oncology and Hematology Care Clinic - Westside | Portland | Oregon | 97225 | Recruiting |
| Providence Portland Medical Center-Westside | Portland | Oregon | 97225 | Recruiting |
| Providence St. Vincent Medical Center- Investigational Drug Services | Portland | Oregon | 97225 | Recruiting |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | Recruiting |
| Northwest Cancer Specialists, P.C. | Portland | Oregon | 97227 | Recruiting |
| Northwest Cancer Specialists, P.C. | Tigard | Oregon | 97223 | Recruiting |
| UPMC Hillman Cancer Center - Beaver | Beaver | Pennsylvania | 15009 | Recruiting |
| UPMC Hillman Cancer Center at Butler Health System | Butler | Pennsylvania | 16001 | Recruiting |
| UPMC Hillman Cancer Center Erie | Erie | Pennsylvania | 16505 | Recruiting |
| UPMC Hillman Cancer Center at Arnold Palmer Pavilion, In Partnership with Excela Health | Greensburg | Pennsylvania | 15601 | Recruiting |
| UPMC Hillman Cancer Center - Pinnacle (Community Osteopathic / Medical Sciences Pavillion) | Harrisburg | Pennsylvania | 17109 | Recruiting |
| UPMC Hillman Cancer Center at Arnold Palmer Pavilion, In Partnership with Excela Health | Irwin | Pennsylvania | 15642 | Recruiting |
| UPMC Hillman Cancer Center - Pinnacle (Ortenzio) | Mechanicsburg | Pennsylvania | 17050 | Recruiting |
| UPMC Hillman Cancer Center - Monroeville | Monroeville | Pennsylvania | 15146 | Recruiting |
| UPMC Hillman Cancer Center - St Margarets | Pittsburgh | Pennsylvania | 15215 | Recruiting |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | Recruiting |
| UPMC Hillman Cancer Center - Passavant (HOA) | Pittsburgh | Pennsylvania | 15237 | Recruiting |
| St. Clair Cancer Center Medical Oncology | Pittsburgh | Pennsylvania | 15243 | Recruiting |
| UPMC Hillman Cancer Center - Washington | Washington | Pennsylvania | 15301 | Recruiting |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | Recruiting |
| Henry-Joyce Cancer Clinic | Nashville | Tennessee | 37232 | Recruiting |
| Texas Oncology - DFW | Dallas | Texas | 75246 | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
| US Oncology Investigational Product Center (IPC) | Irving | Texas | 75063 | Recruiting |
| US Oncology Investigational Products Center (IPC) | Irving | Texas | 75063 | Recruiting |
| Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care | Blacksburg | Virginia | 24060 | Recruiting |
| Oncology & Hematology Associates of Southwest Virginia | Low Moor | Virginia | 24457 | Recruiting |
| Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | Recruiting |
| Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care | Salem | Virginia | 24153 | Recruiting |
| Oncology & Hematology Associates of Southwest Virginia | Wytheville | Virginia | 24382 | Recruiting |
| Providence Regional Cancer Partnership | Everett | Washington | 98201 | Recruiting |
| Providence Regional Medical Center Everett | Everett | Washington | 98201 | Recruiting |
| Northwest Cancer Specialists, P.C. | Vancouver | Washington | 98684 | Recruiting |
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 234 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05253651, 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 Jul 21, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05253651 live on ClinicalTrials.gov.