Trial Profile

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

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 19 Jun 2025

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At a glance

Drugs Fluorouracil (Primary) ; Folinic acid (Primary) ; Levofolinic acid (Primary) ; Oxaliplatin (Primary) ; Trastuzumab (Primary) ; Tucatinib (Primary) ; Bevacizumab; Cetuximab
Indications Adenocarcinoma; Colon cancer; Colorectal cancer; Rectal cancer
Focus Registrational; Therapeutic Use
Acronyms MOUNTAINEER-03
Sponsors Pfizer; Seagen

21 Feb 2025 Planned End Date changed from 30 Apr 2028 to 27 Jul 2029.
21 Feb 2025 Planned primary completion date changed from 30 Aug 2025 to 3 Apr 2026.
06 Feb 2025 Planned primary completion date changed from 31 Aug 2025 to 30 Aug 2025.

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