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MOUNTAINEER-03NCT05253651

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

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
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Record History

The 50 most recent of 106 versions: 50 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial sites reduced: 381 → 366 locationsv106
  2. Primary completion pushed from Apr 3, 2026 to Dec 31, 2027
    • Study completion pushed from Jul 27, 2029 to Jul 3, 2030
    • Study sites: 382 to 381
    v105
  3. Study sites: 383 to 382v104
  4. Study sites: 378 to 383v103
  5. Study sites: 380 to 378v102
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 384 to 380v101
  2. Site details revised at 1 of 384 sitesv100
  3. Study sites: 383 to 384v99
  4. Study sites: 388 to 383v98
  5. Site details revised at 2 of 388 sitesv97
  6. Study sites: 389 to 388v96
  7. Study sites: 388 to 389v95
  8. Study sites: 379 to 388v94
  9. Study sites: 236 to 379v93
  10. Lead sponsor: Seagen Inc. to Seagen, a wholly owned subsidiary of Pfizerv92
  11. Primary completion date: Aug 30, 2025 to Apr 3, 2026
    • Study completion date: Apr 30, 2028 to Jul 27, 2029
    v91
  12. Primary completion date: Aug 31, 2025 to Aug 30, 2025v90
  13. Site contacts updated at 1 of 236 sitesv89
  14. Study sites: 235 to 236v88
  15. Study sites revised (235)v87
  16. Study sites: 234 to 235v86
  17. Study sites: 232 to 234v85
  18. Study sites: 228 to 232v84
  19. Site details revised at 1 of 228 sitesv83
  20. Study sites: 227 to 228v82
  21. Study sites: 225 to 227v81
  22. Eligibility criteria expanded, about 8 words
    • Study sites: 223 to 225
    • Collaborators shortened, about 5 words
    v80
  23. Study sites: 222 to 223v79
  24. Study sites: 221 to 222v78
  25. Study sites: 220 to 221v77
  26. Study sites: 219 to 220v76
  27. Study sites: 218 to 219v75
  28. Site contacts updated at 2 of 218 sitesv74
  29. Site contacts updated at 1 of 218 sitesv73
  30. Study sites: 216 to 218v72
  31. Study sites: 214 to 216v71
  32. Study sites revised (214)v70
  33. Study sites: 213 to 214v69
  34. Study sites: 208 to 213v68
  35. Study sites: 206 to 208v67
  36. Study sites: 205 to 206v66
  37. Study sites: 200 to 205v65
  38. Study sites: 199 to 200v64
  39. Study sites: 197 to 199v63
  40. Study sites: 192 to 197v62
  41. Study sites: 190 to 192v61
  42. Study sites: 188 to 190v60
  43. Study sites: 183 to 188v59
  44. Study sites: 182 to 183v58
  45. Study sites: 171 to 182v57
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR)
Timeframe: Up to approximately 3 years

Secondary (12)

Overall survival (OS)
Confirmed objective response rate (cORR) per RECIST v1.1 by BICR
PFS per RECIST v1.1 by investigator assessment
cORR per RECIST v1.1 by investigator assessment
Duration of response (DOR) per RECIST v1.1 by BICR
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DOR per RECIST v1.1 by investigator assessment
Time to second progression or death (PFS2)
Incidence of adverse events (AEs)
Incidence of dose alterations
Trough concentration (Ctrough)
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQC30) score
Time to meaningful change in EORTC QLQ30 score

Arms and interventions

Tucatinib ArmExperimental

Tucatinib + trastuzumab + mFOLFOX6

Standard of Care ArmActive comparator

Either (1) mFOLFOX6, (2) mFOLFOX6 and bevacizumab, or (3) mFOLFOX6 and cetuximab

Drugs: tucatinib, trastuzumab, bevacizumab, cetuximab, oxaliplatin, leucovorin, levoleucovorin, fluorouracil

Sites

366 sites in 25 countries

United States 132, China 30, Spain 24, Italy 23, France 20, Japan 18, Germany 16, United Kingdom 12, Poland 11, Brazil 10, Belgium 8, Ireland 7, South Korea 7, Argentina 6, Taiwan 6, Austria 5, Canada 5, Greece 5, Netherlands 4, Portugal 4, Australia 3, Chile 3, Norway 3, Slovakia 2, Switzerland 2