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Clinical trial · no report yet · Phase 3

MOUNTAINEER-03

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

  • NCT05253651 ↗
  • Recruiting
  • Seagen, a wholly owned subsidiary of Pfizer
  • 19 commentary sources found
  • Standard

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Commentary we found

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

ChannelFound
YouTube9
Podcasts8
X threads2

The trial

ClinicalTrials.gov
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
Phase
Phase 3
Status
Recruiting
Conditions
Colorectal Neoplasms
Interventions
tucatinib; trastuzumab; bevacizumab; cetuximab; oxaliplatin; leucovorin; levoleucovorin; fluorouracil
Arms
  • Tucatinib Arm · Experimental
  • Standard of Care Arm · Active comparator
Enrollment
400 (estimated)
Primary outcomes
  • Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR)
Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Start
Oct 24, 2022
Primary completion
Dec 31, 2027 (estimated)
Results posted
No
Registry record
NCT05253651 · updated Jul 22, 2026

Publications

linked from the registry
  • Strickler JH, Bekaii-Saab T, Cercek A, Heinemann V, Nakamura Y, Raghav K, Siena S, Tabernero J, Van Cutsem E, Yoshino T, Ramos J, Guan X, Andre T. MOUNTAINEER-03 phase III study design: first-line mFOLFOX6 + tucatinib + trastuzumab for HER2+ metastatic colorectal cancer. Future Oncol. 2025 Feb;21(3):303-311. doi: 10.1080/14796694.2024.2441101. Epub 2024 Dec 26. PubMed 39723627