Status:
RECRUITING
A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
Lead Sponsor:
Seagen, a wholly owned subsidiary of Pfizer
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 27 2029
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05253651
Start Date
October 24 2022
End Date
July 27 2029
Last Update
December 17 2025
Active Locations (378)
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1
Palo Verde Hematology Oncology
Glendale, Arizona, United States, 85304
2
Mayo Clinic Building - Phoenix
Phoenix, Arizona, United States, 85054
3
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
4
Mayo Clinic
Scottsdale, Arizona, United States, 85259