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

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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).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have HER2-positive inoperable or metastatic colorectal cancer.
  • The serious side effects of prior treatments must go away before the study therapy is given.
  • No previous treatment may have been given for advanced colorectal cancer.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Andrea Cercek at 646-888-4189.

Protocol

22-257

Phase

III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators