A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
Recruiting · NCT05253651 · Interventional (participants receive a specific treatment) · Lead sponsor: Seagen, a wholly owned subsidiary of Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum which is locally advanced unresectable or metastatic
- Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides) obtained prior to treatment initiation to a central laboratory
- If archival tissue is not available, a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to start of study treatment
- HER2+ disease as determined by a tissue based assay performed at a central laboratory.
- Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing. For central RAS analysis, tissue sample must be analyzed within 1 year of biopsy date.
- Radiographically measurable disease per RECIST v1.1 with:
- At least one site of disease that is measurable and that has not been previously irradiated, or
- If the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- CNS Inclusion - based on contrast brain magnetic resonance imaging, participants may have any of the following:
- No evidence of brain metastases
- Previously treated brain metastases which are asymptomatic
Exclusion criteria
- Prior systemic anticancer therapy for colorectal cancer (CRC) in the locally advanced unresectable or metastatic setting; note that participants may have received a maximum of 2 doses of mFOLFOX6 in the locally advanced/unresectable or metastatic setting prior to randomization.
- Note: May have received chemotherapy for CRC in the adjuvant setting if it was completed \>6 months prior to enrollment
- Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)
- Previous treatment with anti-HER2 therapy
- Ongoing Grade 3 or higher neuropathy
- Active or untreated gastrointestinal (GI) perforation at the time of screening.
Where it is running
60 locations listed across 19 US states.
- Palo Verde Hematology Oncology - Glendale, Arizona, United States
- Mayo Clinic Building - Phoenix - Phoenix, Arizona, United States
- Mayo Clinic Hospital - Phoenix, Arizona, United States
- Mayo Clinic - Scottsdale, Arizona, United States
- Los Angeles Cancer Network - Anaheim - Anaheim, California, United States
- Kaiser Permanente Anaheim Kraemer Medical Offices - Anaheim, California, United States
- Kaiser Permanente Baldwin Park Medical Center - Baldwin Park, California, United States
- Kaiser Permanente Bellflower Medical Offices - Bellflower, California, United States
- Kaiser Permanente Fontana Medical Center - Fontana, California, United States
- Los Angeles Cancer Network - Fountain Vally - Fountain Valley, California, United States
- Los Angeles Cancer Network - Corporate Office - Glendale, California, United States
- Los Angeles Hematology Oncology Medical Group - Glendale, California, United States
- Los Angeles Hematology Oncology Medical Group - Glendale, California, United States
- Kaiser Permanente South Bay Medical center - Harbor City, California, United States
- Kaiser Permanente Alton/Sand Canyon Medical Offices - Irvine, California, United States
- Los Angeles Hematology Oncology Medical Group - Los Angeles, California, United States
- USC Norris Koreatown - Medical Oncology - Los Angeles, California, United States
- Kaiser Permanente Los Angeles Medical Offices - Los Angeles, California, United States
- Keck Hospital of USC - Los Angeles, California, United States
- Los Angeles General Medical Center - Los Angeles, California, United States
- University of Southern California - Los Angeles, California, United States
- USC/Norris Comprehensive Cancer Center - Los Angeles, California, United States
- Kaiser Permanente West Los Angeles Medical Center - Los Angeles, California, United States
- USC Norris Oncology/Hematology - Newport Beach - Newport Beach, California, United States
- Kaiser Permanente Ontario Medical Center - Ontario, California, United States
- Kaiser Permanente Panorama City Medical Center - Panorama City, California, United States
- Keck Medical Center of USC Pasadena - Pasadena, California, United States
- Los Angeles Hematology Oncology Medical Group - Pasadena, California, United States
- Kaiser Permanente Riverside Medical Center - Riverside, California, United States
- Kaiser Permanente San Diego Mission Road (Regulatory and Lab Supplies) - San Diego, California, United States
- Kaiser Permanente Zion Medical Center - San Diego, California, United States
- Kaiser Permanente San Marcos Medical Offices - San Marcos, California, United States
- Los Angeles Hematology Oncology Medical Group - Van Nuys, California, United States
- Kaiser Permanente Woodland Hills Medical Center - Woodland Hills, California, United States
- Rocky Mountain Cancer Centers, LLP - Aurora, Colorado, United States
- Rocky Mountain Cancer Centers, LLP - Boulder, Colorado, United States
- Rocky Mountain Cancer Centers, LLP - Colorado Springs, Colorado, United States
- Rocky Mountain Cancer Centers, LLP - Denver, Colorado, United States
- Rocky Mountain Cancer Centers, LLP - Denver, Colorado, United States
- Rocky Mountain Cancer Centers, LLP - Lakewood, Colorado, United States
- Rocky Mountain Cancer Centers, LLP - Littleton, Colorado, United States
- Rocky Mountain Cancer Centers, LLP - Lone Tree, Colorado, United States
- Rocky Mountain Cancer Centers, LLP - Longmont, Colorado, United States
- Rocky Mountain Cancer Centers, LLP - Pueblo, Colorado, United States
- Rocky Mountain Cancer Centers, LLP - Thornton, Colorado, United States
- Mount Sinai Medical Center Aventura ER - Aventura, Florida, United States
- Mount Sinai Comprehensive Cancer Center - Miami Beach, Florida, United States
- Mount Sinai Medical Center - Miami Beach, Florida, United States
- Emory University Hospital Midtown - Atlanta, Georgia, United States
- Emory University Hospital - Atlanta, Georgia, United States
- Winship Cancer Institute - Atlanta, Georgia, United States
- Emory Saint Joseph's Hospital - Atlanta, Georgia, United States
- Alliance for Multispecialty Research LLC. - Merriam, Kansas, United States
- Norton Cancer Institute - Downtown - Louisville, Kentucky, United States
- Norton Cancer Institute, Downtown - Louisville, Kentucky, United States
- Norton Hospital - Louisville, Kentucky, United States
- Norton Audubon Hospital - Louisville, Kentucky, United States
- Norton Cancer Institute, Audubon Hospital Campus - Louisville, Kentucky, United States
- Norton Brownsboro Hospital - Louisville, Kentucky, United States
- Norton Cancer Institute, Brownsboro Hospital Campus - Louisville, Kentucky, United States
Showing 60 of 366 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →