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

• Status: Not yet recruiting
• Trial end date: 2028-04-30

Summary

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 test 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 a group to the tucatinib or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either:

• mFOLFOX6 alone,

• mFOLFOX6 with bevacizumab, or

• mFOLFOX6 with cetuximab These are drugs that are used to treat this type of cancer.

• Phase: Phase 3

Details

• Lead Sponsor: Seagen Inc.
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Bevacizumab; Cetuximab; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin; Trastuzumab; Tucatinib