Tucatinib + trastuzumab + mFOLFOX6 vs standard of care in 1L HER2+ metastatic colorectal cancer
Research type
Research Study
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
IRAS ID
1004513
Contact name
Scott Knowles
Contact email
Sponsor organisation
Seagen Inc.
Eudract number
2021-002672-40
Clinicaltrials.gov Identifier
Research summary
Seagen Inc. (the Sponsor) is running an open-label, randomised, phase 3 study to evaluate the efficacy and safety of Tucatinib when combined with trastuzumab and mFOLFOX6, compared to mFOLFOX6 given alone, or with either Cetuximab or Bevacizumab as First-line Treatment for participants with HER2+ Metastatic Colorectal Cancer.
Metastatic colorectal cancer (mCRC) is the 2nd leading cause of cancer death worldwide, with patients surviving for only 2-3 years after receiving their diagnosis. There are currently no HER2-targeted agents approved to treat mCRC, and those that are approved are not curative. However, recent research has supported the use of targeted anti-HER2 therapies in the treatment of mCRC, acting to inhibit carcinogenic HER2 function. This study aims to investigate the efficacy and side-effects of combining different anti-HER2 therapies, with a specific focus on Tucatinib, a HER2 tyrosine kinase inhibitor.
The study plans to involve approximately 400 participants who have HER2+ colorectal cancer. Initial screening will check eligibility for the study. Eligible participants will be randomised in a 1:1 ratio, either to the experimental arm combining Tucatinib with trastuzumab and mFOLFOX6, or to the Standard of Care (SOC) arm administering mFOLFOX6 alone, or with either bevacizumab or cetuximab. Participants in the experimental arm will be administered Tucatinib daily, taken orally (by mouth). They will also be administered mFOLFOX6 by vein, once every 2 weeks, and trastuzumab once every 3 weeks. Those in the SOC arm will be given mFOLFOX6 by vein, once every 2 weeks, alone or along with either bevacizumab once every 2 weeks or cetuximab once a week. Treatment is expected to last a minimum of 6 weeks and participation will involve a minimum of 8 visits to the study site.
Study assessments include: vital signs, collecting blood, urinalysis, electrocardiogram, physical examination, CT or MRI scans, Echocardiograms or MUGA scans and possible tumour biopsy.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
22/NE/0069
Date of REC Opinion
27 May 2022
REC opinion
Further Information Favourable Opinion