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.

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ClinicalTrials.gov public records Last synced May 5, 2026, 7:08 PM EDT

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

Study identification

NCT ID: NCT05253651
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Seagen, a wholly owned subsidiary of Pfizer; Industry
Enrollment: 400 participants

Conditions and interventions

Conditions

Colorectal Neoplasms

Interventions

bevacizumab Drug
cetuximab Drug
fluorouracil Drug
leucovorin Drug
levoleucovorin Drug
oxaliplatin Drug
trastuzumab Drug
tucatinib 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: Apr 2, 2026
Completion: Jul 26, 2029
Last update posted: Apr 6, 2026

2022 – 2029

United States locations

U.S. sites: 129
U.S. states: 19
U.S. cities: 83

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 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
Grady Health System	Atlanta	Georgia	30303	Recruiting
Emory University Hospital Midtown	Atlanta	Georgia	30308	Recruiting
Emory University Hospital	Atlanta	Georgia	30322	Recruiting
Winship Cancer Institute	Atlanta	Georgia	30322	Recruiting
Alliance for Multispecialty Research LLC.	Merriam	Kansas	66204	Terminated
Baptist Health Lexington	Lexington	Kentucky	40503	Recruiting
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.	Portland	Oregon	97213	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 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
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 253 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 Apr 6, 2026 · Synced May 5, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05253651 live on ClinicalTrials.gov.

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