A Phase III Study of Tucatinib with Trastuzumab and mFOLFOX6 Chemotherapy versus Standard Care as Initial Treatment for HER2+ Metastatic Colorectal Cancer

In the U.S.

Full Title

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 (WIRB)

Purpose

This study is comparing the effectiveness of combination chemotherapy plus tucatinib and trastuzumab versus combination chemotherapy alone in people with metastatic colorectal cancer that is positive for the HER2 protein. The combination chemotherapy is called mFOLFOX6 (oxaliplatin, leucovorin or levoleucovorin, and fluorouracil) and it is a standard treatment for advanced colorectal cancer.

Tucatinib is designed to target and turn off HER2, which may make cancer cells die or slow down their growth. Trastuzumab attaches to HER2 and may also slow down tumor cell growth. Patients may also receive the medications bevacizumab or cetuximab, which are standard colorectal cancer drugs.

Participants in this study will be randomly assigned to receive tucatinib, trastuzumab, and mFOLFOX6 or mFOLFOX6 alone. The study doctors will choose whether they also receive bevacizumab or cetuximab. Tucatinib is taken orally (by mouth) and the other medications are given intravenously (by vein).