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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
Eligible participants will be randomly allocated to either the Experimental Arm or the Active Comparator Arm. In the Experimental Arm, participants will receive tucatinib + trastuzumab + mFOLFOX6. Tucatinib will be given orally twice daily at a dose of 300mg. Trastuzumab will be given intravenously (IV) first at a 8mg/kg loading dose on Cycle 1 day 1, followed by 6mg/kg every 3 weeks after that. mFOLFOX6 consists of oxaliplatin, fluorouracil + either leucovorin or levoleucovorin. Oxaliplatin will be given via IV every 2 weeks at a dose of 85mg/m2. Leucovorin will be given via IV every 2 weeks at a dose of 400mg/m2. Levoleucovorin will be given via IV every 2 weeks at a dose of 200mg, and may be given in place of leucovorin. Finally, fluorouracil will be given by IV bolus at a dose of 400mg/m2, then 2400mg/m2 given by continuous IV infusion every 2 weeks. In the Active Comparator Arm, participants will receive one of three standard of care treatment regiments: mFOLFOX6 alone, mFOLFOX6 + bevacizumab, or mFOLFOX6 + cetuximab. mFOLFOX6 will be given as described in the Experimental Arm. Where bevacizumab is given, it will be administered via IV every 2 weeks at a dose of 5mg/kg. Where cetuximab is given, it will be administered via IV first at a 400mg/m2 loading dose on Cycle 1 day 1, followed by 250mg/m2 by IV weekly.