Last updated 38 days ago
A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
400 patients around the world
Available in United States, Spain, Chile, Argentina
Seagen Inc.
13Research sites
400Patients around the world
This study is for people with
Colorectal cancer
Colon cancer
Rectal cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum which is locally advanced unresectable or metastaticAble to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides) obtained prior to treatment initiation to a central laboratory. If archival tissue is not available, a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to start of study treatmentHER2+ disease as determined by a tissue based assay performed at a central laboratory.Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing. For central RAS analysis, tissue sample must be analyzed within 1 year of biopsy date.Radiographically measurable disease per RECIST v1.1 with: At least one site of disease that is measurable and that has not been previously irradiated, or If the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiationEastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1CNS Inclusion - based on contrast brain magnetic resonance imaging, participants may have any of the following: No evidence of brain metastases, Previously treated brain metastases which are asymptomatic
- Prior systemic anticancer therapy for colorectal cancer (CRC) in the metastatic setting; note that participants may have received a maximum of 2 doses of mFOLFOX6 in the locally advanced/unresectable or metastatic setting prior to randomization. Note: May have received chemotherapy for CRC in the adjuvant setting if it was completed >6 months prior to enrollmentRadiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)Previous treatment with anti-HER2 therapyOngoing Grade 3 or higher neuropathyGI perforation within 12 months of enrollment
Sites
Hospital Británico de Buenos Aires - CABA
Recruiting
Centro Médico Privado CEMAIC - Córdoba
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Instituto Oncológico de Córdoba IONC - Fundación Richardet Longo
Recruiting
Hospital Nossa Senhora da Conceição
Recruiting
Oncocentro APYS - Valparaíso
Recruiting
Centro de Estudios Clínicos SAGA - CECSAGA
Recruiting
Hospital Universitario La Paz
Recruiting
Hospital Universitario 12 de Octubre
Recruiting
StudyMOUNTAINEER-03
SponsorSeagen Inc.
Study typeInterventional
Conditions
Colorectal cancerColon cancerRectal cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05253651
