MOUNTAINEER-03: This phase III study is seeking to understand whether targeted therapy (tucatinib + trastuzumab) plus combination chemotherapy (mFOLFOX6) works better than standard of care treatment regimens (such as mFOLFOX6 alone, or given with either cetuximab or bevacizumab), in people with HER2 positive colorectal cancerAn 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

Summary

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.

Conditions

This trial is treating patients with HER2+ bowel cancer.

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