A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer

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

Trial Details

NCT ID
NCT05253651
Phase
PHASE3
Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • tucatinib
  • trastuzumab
  • bevacizumab
  • cetuximab
  • oxaliplatin
  • leucovorin
Locations (sample)
  • Glendale, Arizona, United States|33.53865,-112.18599
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Scottsdale, Arizona, United States|33.50921,-111.89903
  • Anaheim, California, United States|33.83529,-117.9145

Key Eligibility 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 prio…
  • 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 st…
  • HER2+ disease as determined by a tissue based assay performed at a central laboratory.

For full eligibility, visit ClinicalTrials.gov.

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