A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer (MOUNTAINEER-03)
Colorectal Neoplasms
About this trial
This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Colorectal Cancer, CRC, Seattle Genetics
Eligibility Criteria
Inclusion Criteria:
- Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum which is metastatic and/or unresectable
Able 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 treatment
- HER2+ 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
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 radiation
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
CNS 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
Exclusion Criteria:
Prior systemic anticancer therapy for colorectal cancer (CRC) in the metastatic setting
- May have received chemotherapy for CRC in the adjuvant setting if it was completed >6 months prior to enrollment
- Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)
- Previous treatment with anti-HER2 therapy
- Ongoing Grade 3 or higher neuropathy
- GI perforation within 12 months of enrollment
Sites / Locations
- Palo Verde Cancer SpecialistsRecruiting
- Mayo Clinic ArizonaRecruiting
- Pacific Cancer Medical CenterRecruiting
- Los Angeles Cancer NetworkRecruiting
- Kaiser Permanente Southern CaliforniaRecruiting
- University of Southern CaliforniaRecruiting
- University of Southern CaliforniaRecruiting
- Providence Medical Foundation
- Rocky Mountain Cancer Centers - AuroraRecruiting
- Mount Sinai Medical Center / FloridaRecruiting
- Woodlands Medical SpecialistsRecruiting
- MidAmerica Cancer Center, LLCRecruiting
- Baptist Health LexingtonRecruiting
- Norton Cancer InstituteRecruiting
- Mayo Clinic RochesterRecruiting
- HealthPartners InstituteRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Duke University Medical CenterRecruiting
- FirstHealth of the CarolinasRecruiting
- Gabrail Cancer Center Research, LLC
- Providence Portland Medical CenterRecruiting
- Avera Cancer InstituteRecruiting
- Texas Oncology - Baylor Sammons Cancer CenterRecruiting
- MD Anderson Cancer Center / University of TexasRecruiting
- Texas Oncology - McKinneyRecruiting
- Texas Oncology - Northeast TexasRecruiting
- Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer CareRecruiting
- Providence Regional Medical Center EverettRecruiting
- Northwest Cancer Specialists, P.C.Recruiting
- Instituto Alexander FlemingRecruiting
- CEMAIC - Centro Medico PrivadoRecruiting
- Instituto Oncologico de CordobaRecruiting
- Instituto Medico de la Fundacion Estudios ClinicosRecruiting
- St Vincent's Hospital MelbourneRecruiting
- The Alfred HospitalRecruiting
- Townsville Cancer CenterRecruiting
- Institut Jules BordetRecruiting
- Universitair Ziekenhuis AntwerpenRecruiting
- Hopital de JolimontRecruiting
- Hospital Nossa Senhora da ConceiçãoRecruiting
- University of Ottawa / Ottawa General HospitalRecruiting
- Sunnybrook Health Sciences CentreRecruiting
- Jewish General HospitalRecruiting
- Centro de Estudios Clínicos SAGARecruiting
- Oncocentro APYSRecruiting
- Beijing Cancer HospitalRecruiting
- The Second Xiangya Hospital of Central South UniversityRecruiting
- Hunan Cancer HospitalRecruiting
- Affiliated Hospital of Chengde Medical UniversityRecruiting
- 900TH Hospital of Joint Logistics Support ForceRecruiting
- The Sixth Affiliated Hospital of Sun Yat-sen UniversityRecruiting
- The Second Affiliated Hospital of Hainan Medical UniversityRecruiting
- Hainan General HospitalRecruiting
- The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
- Zhejiang University School of MedicineRecruiting
- Harbin Medical University Cancer HospitalRecruiting
- Jinan Central HospitalRecruiting
- Shandong Cancer HospitalRecruiting
- The First Hospital Affiliated to Liaoning Medical CollegeRecruiting
- The First Hospital of Lanzhou UniversityRecruiting
- Linyi Cancer HospitalRecruiting
- Meizhou People's Hospital - Guangdong ProvinceRecruiting
- The First Affiliated Hospital of Nanchang UniversityRecruiting
- The Second Affiliated Hospital of Nanchang UniversityRecruiting
- Nanyang Second General HospitalRecruiting
- Shanghai General HospitalRecruiting
- The First Hospital of China Medical UniversityRecruiting
- Liaoning Cancer Hospital and InstituteRecruiting
- The First Affiliated Hospital of Soochow UniversityRecruiting
- Shanxi Province Cancer HospitalRecruiting
- Tangshan People's HospitalRecruiting
- Hubei Cancer HospitalRecruiting
- Henan Provincial People's HospitalRecruiting
- Center Georges Francois LeclercRecruiting
- Hopital Saint Louis, APHPRecruiting
- Hopital Saint-AntoineRecruiting
- CHU Saint Etienne Hopital NordRecruiting
- Institut de Cancerologie de I'Ouest - Site Saint-HerblainRecruiting
- Beaumont HospitalRecruiting
- Chiba Cancer CenterRecruiting
- National Cancer Center HospitalRecruiting
- National Hospital Organization Kyushu Cancer CenterRecruiting
- National Cancer Center Hospital EastRecruiting
- St. Marianna University School of MedicineRecruiting
- Kagawa University HospitalRecruiting
- Kobe City Hospital Organization Kobe City Medical Center General HospitalRecruiting
- The Cancer Institute Hospital of JFCRRecruiting
- NHO Shikoku Cancer CenterRecruiting
- Osaka General Medical Center (Kyuseiki Sogo Iryo C)Recruiting
- Kindai University HospitalRecruiting
- National Hospital Organization Hokkaido Cancer CenterRecruiting
- Osaka Medical and Pharmaceutical University HospitalRecruiting
- Kanagawa Cancer CenterRecruiting
- Gachon University Gil Medical CenterRecruiting
- Korea University Anam HospitalRecruiting
- Seoul National University HospitalRecruiting
- Severance Hospital, Yonsei University Health SystemRecruiting
- Asan Medical Center - OncologyRecruiting
- Korea University Guro HospitalRecruiting
- Samsung Medical CenterRecruiting
- Netherlands Cancer InstituteRecruiting
- Narodny Onkologicky UstavRecruiting
- POKO PopradRecruiting
- Hospital General Universitario AlicanteRecruiting
- Hospital Universitari Vall d'HebronRecruiting
- Hospital Clinic de BarcelonaRecruiting
- Institut Catala d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)Recruiting
- Hospital Universitario Ramon y CajalRecruiting
- Hospital Universitario 12 de OctubreRecruiting
- Hospital Universitario La PazRecruiting
- Complejo Hospitalario Universitario de Ourense (CHOU)Recruiting
- Hospital Universitario Central de AsturiasRecruiting
- Complejo Hospitalario de NavarraRecruiting
- Hospital Universitario Marques de ValdecillaRecruiting
- Hospital Universitario Virgen del RocioRecruiting
- Consorci Hospital General Universitari de Valencia (CHGUV)Recruiting
- Universitätsspital ZürichRecruiting
- Chang Gung Memorial Hospital - KaohsiungRecruiting
- National Cheng-Kung University HospitalRecruiting
- Taipei Veterans General HospitalRecruiting
- National Taiwan University HospitalRecruiting
- Chang Gung Memorial Hospital - LinkouRecruiting
- University Hospitals Bristol and Weston NHS Foundation TrustRecruiting
- Hull University Teaching Hospitals NHS TrustRecruiting
- Leeds Teaching Hospitals TrustRecruiting
- Guy's and St Thomas' NHS FoundationRecruiting
- Imperial College Healthcare NHS TrustRecruiting
- The Newcastle upon Tyne Hospitals NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Tucatinib Arm
Standard of Care Arm
Tucatinib + trastuzumab + mFOLFOX6
mFOLFOX6 + (bevacizumab OR cetuximab). Either (1) mFOLFOX6, (2) mFOLFOX6 and bevacizumab, or (3) mFOLFOX6 and cetuximab