Trial details
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
To find out more about this trial and your cancer treatment options, please speak with your doctor.
Trial short name: MOUNTAINEER-03
Official 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
Principal Investigator: Dr. Sheron Perera
Cancer type: Gastrointestinal
Cancer location: Gastrointestinal
Disease stage: Early Cancer
Trial phase: Phase 3
Intervention: Drug: tucatinib Drug: trastuzumab Drug: bevacizumab Drug: cetuximab Drug: oxaliplatin Drug: leucovorin Drug: levoleucovorin Drug: fluorouracil
Registration #:
NCT05253651 
Contact e-mail: cancerclinicaltrials@sunnybrook.ca
Trial description:
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 the tucatinib group 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 mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.
Key Inclusion Criteria: • Have histologically and/or cytologically documented adenocarcinoma of the colon or rectum, which is metastatic and/or unresectable • Able to provide tumor tissue block/slides for HER2+ analysis and have HER2+ disease as determined by tissue-based investigational HER2 IHC and ISH assays performed at a sponsor-defined central laboratory • Have RAS WT disease as determined by local or central testing • Life expectancy of at least 3 months. • ECOG Performance Status of 0 to 1. • Have measurable disease per RECIST 1.1 as assessed by the site Key Exclusion Criteria: • Have received prior systemic anticancer therapy in the metastatic setting including investigational agents within 4 weeks before the first dose of study intervention. • Have previously received radiation therapy within 14 days prior to enrollment • Have previously been treated with anti-HER2 therapy • Have clinically significant cardiopulmonary disease • Have a history of gastrointestinal (GI) perforation within 12 months of enrollment • Known DPD deficiency • Active Hep B , Hep C
