A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer (MOUNTAINEER-03)

July 21, 2026 updated by: Seagen, a wholly owned subsidiary of Pfizer

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

This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.

Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable).

Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either:

mFOLFOX6 alone,
mFOLFOX6 with bevacizumab, or
mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.

Study Overview

Status

Recruiting

Conditions

Colorectal Neoplasms

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Pfizer CT.gov Call Center
Phone Number: 1-800-718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

Argentina
- - Buenos Aires, Argentina, 1426
    - Recruiting
    - Instituto Medico Especializado Alexander Fleming
  - CABA, Argentina, 1280
    - Recruiting
    - Hospital Britanico de Buenos Aires
  - Córdoba, Argentina, X5001 HWE
    - Recruiting
    - IONC Instituto Oncologico de Cordoba Fundacion Richardet Longo
  - Córdoba, Argentina
    - Recruiting
    - CEMAIC - Centro Medico Privado
- Buenos Aires
  - Pergamino, Buenos Aires, Argentina, 2700
    - Recruiting
    - Centro de Investigacion Pergamino SA
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina, S2000DEJ
    - Recruiting
    - Instituto Medico de la Fundacion Estudios Clinicos
Australia
- New South Wales
  - Camperdown, New South Wales, Australia, 2050
    - Not yet recruiting
    - Chris O'Brien Lifehouse
- Queensland
  - Woolloongabba, Queensland, Australia, 4102
    - Recruiting
    - Princess Alexandra Hospital
- Victoria
  - Fitzroy, Victoria, Australia, 3065
    - Recruiting
    - St Vincent's Hospital
Austria
- - Salzburg, Austria, 5020
    - Recruiting
    - Uniklinikum Salzburg, Landeskrankenhaus
  - Vienna, Austria, 1090
    - Not yet recruiting
    - AKH - Medizinische Universitat Wien
  - Wels, Austria, 4600
    - Recruiting
    - Klinikum Wels-Grieskirchen GmbH Austria
  - Wiener Neustadt, Austria, 2700
    - Not yet recruiting
    - Landesklinikum Wiener Neustadt
- Upper Austria
  - Wels, Upper Austria, Austria, A-4600
    - Recruiting
    - Klinikum Wels-Grieskirchen GmbH Austria
Belgium
- - Anderlecht, Belgium, 1070
    - Recruiting
    - Institut Jules Bordet
  - Brussels, Belgium, 1200
    - Recruiting
    - Cliniques Universitaires Saint-Luc
  - Edegem, Belgium, 2650
    - Recruiting
    - UZA
  - Haine-Saint-Paul, Belgium, 7100
    - Recruiting
    - CHU HELORA - Hopital de Jolimont
  - Leuven, Belgium, 3000
    - Not yet recruiting
    - Universitair Ziekenhuis Leuven
  - Liège, Belgium, 4000
    - Recruiting
    - Centre Hospitalier Chretien - Clinique MontLégia
  - Turnhout, Belgium, 2300
    - Recruiting
    - Maag-,Darm- en Leverziekten AZ Turnhout
  - Turnhout, Belgium, 2300
    - Recruiting
    - Oncologisch Dagziekenhuis AZ Turnhout Campus Sint-Elisabeth
Brazil
- - São Paulo, Brazil, 01245-000
    - Recruiting
    - ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira.
- Paraná
  - Curitiba, Paraná, Brazil, 80810-050
    - Recruiting
    - Cionc-Centro Integrado de Oncologia de Curitiba
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
    - Recruiting
    - Centro Integrado de Pesquisa em Oncologia CIPO-GHC / Hospital Nossa Senhora da Conceicao
- Rio de Janeiro
  - Barra da Tijuca, Rio de Janeiro, Brazil, 22.775-001
    - Recruiting
    - Instituto De Educação, Pesquisa e Gestão em Saúde - Instituto Américas
  - Rio de Janeiro, Rio de Janeiro, Brazil, 22775-001
    - Recruiting
    - Institute de Educacao, Pesquisa e Gestao em Saude - Instituto COI
  - Rio de Janeiro, Rio de Janeiro, Brazil, 22793-080
    - Recruiting
    - Institute de Educacao, Pesquisa e Gestao em Saude - Instituto COI
- São Paulo
  - Barretos, São Paulo, Brazil, 14784-400
    - Recruiting
    - Hospital de Cancer de Barretos/Fundacao Pio XII
  - Jaú, São Paulo, Brazil, 17210-120
    - Recruiting
    - Centro de Pesquisas Clínicas da Fundação Doutor Amaral Carvalho
  - Santo André, São Paulo, Brazil, 09060-650
    - Recruiting
    - CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia.
  - São José do Rio Preto, São Paulo, Brazil, CEP 15090-000
    - Recruiting
    - Fundação Faculdade Regional de Medicina de São José do Rio Preto
Canada
- Ontario
  - Ottawa, Ontario, Canada, K1H 8L6
    - Recruiting
    - The Ottawa Hospital Cancer Centre
  - Toronto, Ontario, Canada, M5G 1X5
    - Recruiting
    - Mount Sinai Hospital
  - Toronto, Ontario, Canada, M4N 3M5
    - Recruiting
    - Sunnybrook Research Institute
- Quebec
  - Montreal, Quebec, Canada, H3T 1E2
    - Recruiting
    - Jewish General Hospital
    - Principal Investigator:
      
      Petr Kavan
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N 4H4
    - Recruiting
    - Saskatoon Cancer Centre
    - Principal Investigator:
      
      Osama Ahmed
Chile
- - Concepción, Chile
    - Recruiting
    - Biocenter
  - Santiago, Chile
    - Recruiting
    - Centro de Estudios Clinicos SAGA
- Valparaiso
  - Viña del Mar, Valparaiso, Chile
    - Recruiting
    - Oncocentro APYS
China
- - Beijing, China, 100142
    - Active, not recruiting
    - Beijing Cancer Hospital
  - Changsha, China, 410013
    - Active, not recruiting
    - Hunan Cancer Hospital
  - Chongqing, China, 400042
    - Active, not recruiting
    - Army Specialty Medical Center of The Chinese People's Liberation Army
  - Shanghai, China, 201620
    - Active, not recruiting
    - Shanghai General Hospital
- Fujian
  - Fuzhou, Fujian, China, 350001
    - Active, not recruiting
    - Fujian Medical University Union Hospital
- Gansu
  - Lanzhou, Gansu, China, 730000
    - Active, not recruiting
    - The First Hospital of Lanzhou University
- Guangdong
  - Guangzhou, Guangdong, China, 510655
    - Active, not recruiting
    - The Sixth Affiliated Hospital, Sun Yat-sen University
  - Meizhou, Guangdong, China, 514031
    - Active, not recruiting
    - Meizhou People's Hospital
- Hainan
  - Haikou, Hainan, China, 570216
    - Active, not recruiting
    - The Second Affiliated Hospital of Hainan Medical University
- Hebei
  - Chengde, Hebei, China, 067000
    - Active, not recruiting
    - Affiliated Hospital of Chengde Medical University
  - Chengde, Hebei, China, 067055
    - Active, not recruiting
    - Affiliated Hospital of Chengde Medical University
  - Tangshan, Hebei, China, 063001
    - Active, not recruiting
    - Tangshan People's Hospital
- Heilongjiang
  - Harbin, Heilongjiang, China, 150081
    - Active, not recruiting
    - Harbin Medical University Cancer Hospital
- Henan
  - Nanyang, Henan, China, 473009
    - Recruiting
    - Nanyang Second General Hospital
  - Zhengzhou, Henan, China, 450003
    - Active, not recruiting
    - Henan Provincial People's Hospital
- Hubei
  - Wuhan, Hubei, China, 430000
    - Active, not recruiting
    - Hubei Cancer Hospital
- Hunan
  - Changsha, Hunan, China, 410011
    - Active, not recruiting
    - The second Xiangya hospital of central south university
- Jiangsu
  - Changzhou, Jiangsu, China, 213003
    - Active, not recruiting
    - The First People's Hospital Of Changzhou
  - Suzhou, Jiangsu, China, 215031
    - Active, not recruiting
    - The First Affiliated Hospital of Suzhou University
  - Xuzhou, Jiangsu, China, 221009
    - Active, not recruiting
    - Xuzhou Central Hospital
- Jiangxi
  - Nanchang, Jiangxi, China, 330006
    - Active, not recruiting
    - The First Affiliated Hospital Of Nanchang University
- Liaoning
  - Jinzhou, Liaoning, China, 121001
    - Active, not recruiting
    - The First Affiliated Hospital of Jinzhou Medical University
  - Shenyang, Liaoning, China, 110042
    - Active, not recruiting
    - Liaoning Cancer Hospital & Institute
- Shandong
  - Jinan, Shandong, China, 250117
    - Active, not recruiting
    - Shandong Cancer Hospital
  - Jinan, Shandong, China, 250013
    - Active, not recruiting
    - Jinan Central Hospital
  - Linyi, Shandong, China, 276034
    - Active, not recruiting
    - Linyi Cancer Hospital
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 200092
    - Active, not recruiting
    - Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine
- Shanxi
  - Taiyuan, Shanxi, China, 030013
    - Active, not recruiting
    - Shanxi Province Cancer Hospital
- Zhejiang
  - Hangzhou, Zhejiang, China, 310009
    - Active, not recruiting
    - The Second Affiliated hospital of Zhejiang University School of Medicine
  - Hangzhou, Zhejiang, China, 310016
    - Active, not recruiting
    - Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
France
- - Avignon, France, 84918
    - Recruiting
    - Institut Sainte Catherine
  - Brest, France, 29200
    - Recruiting
    - CHU Brest Hopital Cavale Blanche
    - Principal Investigator:
      
      Jean-Philippe Metges
  - Clermont-Ferrand, France, 63100
    - Recruiting
    - Chu Estaing
  - Créteil, France, 94000
    - Recruiting
    - Hopital Henri Mondor
  - Dijon, France, 21079
    - Terminated
    - Center Georges-Francois Leclerc
  - Lyon, France, 69437
    - Recruiting
    - Hôpital Edouard Herriot
  - Marseille, France, 13285
    - Recruiting
    - Hôpital Saint-Joseph
  - Nantes, France, 44093
    - Recruiting
    - Centre Hospitalier Universitaire Nantes-Hotel Dieu
  - Nice, France, 06189
    - Recruiting
    - Centre Antoine Lacassagne
  - Paris, France, 75010
    - Recruiting
    - Hôpital Saint-Louis
  - Paris, France, 75012
    - Recruiting
    - Hôpital Saint-Antoine
  - Paris, France, 75015
    - Recruiting
    - Hôpital Européen Georges Pompidou
  - Pessac, France, 33604
    - Not yet recruiting
    - CHU Bordeaux Hopital Haut Leveque
  - Poitiers, France, 86000
    - Recruiting
    - CHU Poitiers
  - Rouen, France, 76031
    - Not yet recruiting
    - CHU de Rouen
  - Saint-Herblain, France, 44805 Cedex
    - Recruiting
    - Institut de Cancérologie de l'Ouest - Saint-Herblain
  - Saint-Priest-en-Jarez, France, 42270
    - Recruiting
    - Centre Hospitalier Universitaire Sainte-Etienne - Hopital Nord
  - Strasbourg, France, 67033
    - Recruiting
    - Institut de Cancérologie Strasbourg Europe
  - Toulouse, France, 31059
    - Recruiting
    - CHU Toulouse-Rangueil
- Other
  - Besançon, Other, France, 25000
    - Recruiting
    - Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz
Germany
- - Amberg, Germany, 92224
    - Recruiting
    - Klinikum St. Marien Amberg
  - Berlin, Germany, 13353
    - Recruiting
    - Charité - Universitätsmedizin Berlin
  - Berlin, Germany, 13353
    - Recruiting
    - Charité - Universitätsmedizin Berlin Campus Virchiow-Klinikum Zentralapotheke
  - Chemnitz, Germany, 09116
    - Recruiting
    - Klinikum Chemnitz gGmbH
  - Dresden, Germany, 01307
    - Recruiting
    - Technische Universität Dresden, Medizinische Fakultät Carl Gustav Carus
  - Dresden, Germany, 01307
    - Recruiting
    - Gemeinschaftspraxis Hämatologie - Onkologie
  - Hamburg, Germany, 20249
    - Recruiting
    - Hämatologisch Onkologische Praxis Eppendorf (HOPE)
  - Hamburg, Germany, 22453
    - Recruiting
    - Asklepios Kliniken Hamburg GmbH
  - Hamburg, Germany, 22763
    - Recruiting
    - Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona
  - Hanover, Germany, 30625
    - Recruiting
    - Medizinische Hochschule Hannover (MHH)
  - München, Germany, 81675
    - Recruiting
    - Klinikum rechts der Isar der Technischen Universitaet Muenchen
  - Ulm, Germany, 89081
    - Recruiting
    - Universitaetsklinikum Ulm
- Bavaria
  - Munich, Bavaria, Germany, D-81675
    - Recruiting
    - CCC Muenchen TUM
  - München, Bavaria, Germany, D-81377
    - Recruiting
    - LMU Klinikum - Campus Großhadern
- Lower Saxony
  - Hanover, Lower Saxony, Germany, 30625
    - Recruiting
    - Medizinische Hochschule Hannover (MHH)
- Saxony
  - Leipzig, Saxony, Germany, 04103
    - Terminated
    - Universitätsklinikum Leipzig
Greece
- - Athens, Greece, 11528
    - Recruiting
    - Evgenidion Clinic Agia Trias Oncology Department
- Attikí
  - Athens, Attikí, Greece, 11525
    - Recruiting
    - Athens Medical Center - Psychikon branch
- Chaidari
  - Athens, Chaidari, Greece, 124 62
    - Not yet recruiting
    - University General Hospital "Attikon"
- Crete
  - Heraklion, Crete, Greece, 71500
    - Not yet recruiting
    - "University General Hospital of Heraklion Oncology Unit "
- Thessaloniki
  - Nea Efkarpia, Thessaloniki, Greece, 56403
    - Recruiting
    - "Papageorgiou" General Hospital of Thessaloniki 2nd Internal Medicine/Oncology Clinic of Aristotle
Ireland
- - Cork, Ireland, T12 DV56
    - Recruiting
    - Bon Secours Hospital
  - Cork, Ireland, T12 DC4A
    - Recruiting
    - Cork University Hospital,Department of Medical Onncology
  - Dublin, Ireland, D07 R2WY
    - Recruiting
    - Mater Misericordiae University Hospital
  - Dublin, Ireland, D09 V2N0
    - Recruiting
    - Beaumont Hospital
  - Dublin, Ireland, D07 WKW8
    - Recruiting
    - Mater Private Hospital
  - Dublin, Ireland, D04 T6F4
    - Recruiting
    - St Vincents University Hospital
  - Waterford, Ireland, X91 ER8E
    - Recruiting
    - University Hospital Waterford
Italy
- - Foggia, Italy, 71122
    - Recruiting
    - Struttura Semplice Dipartimentale di Oncologia Medica e Terapia Biomolecolare Azienda Ospedaliero
  - Genova, Italy, 16132
    - Recruiting
    - IRCCS Azienda Ospedaliera Metropolitana (IRCCS AOM)
  - Pavia, Italy, 27100
    - Recruiting
    - Fondazione IRCCS Policlinico San Matteo
  - Reggio Emilia, Italy, 42123
    - Recruiting
    - S.C Oncologia Arcispedale Santa Maria Nuova
  - Sondrio, Italy, 23100
    - Recruiting
    - ASST della Valtellina e dell'alto Lario - Presidio Ospedaliero di Sondrio
  - Verona, Italy, 37134
    - Recruiting
    - Centro Ricerche Cliniche di Verona srl
  - Verona, Italy, 37134
    - Recruiting
    - U.O.C. Oncologia Azienda Ospedaliera Universitaria lntegrata (AOUI) di Verona
- Cagliari
  - Monserrato, Cagliari, Italy, 09042
    - Recruiting
    - Azienda Ospedaliera Universitaria Cagliari
  - Monserrato, Cagliari, Italy, 09042
    - Recruiting
    - Farmacia AOU Cagliari - Presidio Ospedaliero ' Duilio Casula' di Monserrate
- Campania
  - Avellino, Campania, Italy, 83100
    - Recruiting
    - UOC Oncologia Medica - Dipartimento Onco Ematologico AORN San Giuseppe Moscati di Avellino
- Lazio
  - Rome, Lazio, Italy, 00168
    - Recruiting
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Lecce
  - Tricase, Lecce, Italy, 73039
    - Recruiting
    - UOC Oncologia, Azienda Ospedaliera Cardinale Giovanni Panico
- Lombardy
  - Brescia, Lombardy, Italy, 25124
    - Recruiting
    - Fondazione Poliambulanza Istituto Ospedaliero
  - Milan, Lombardy, Italy, 20133
    - Recruiting
    - Fondazione IRCCS Istituto Nazionale dei Tumori
  - Milan, Lombardy, Italy, 20141
    - Recruiting
    - lstituto Europeo di Oncologia
  - Milan, Lombardy, Italy, 20162
    - Recruiting
    - Niguarda Cancer Center Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
- Naples
  - Naples, Naples, Italy, 80131
    - Recruiting
    - UOC Oncoematologia
- Other
  - Verona, Other, Italy, 37134
    - Recruiting
    - Servizio Farmacia Azienda Ospedaliera Universitaria lntegrata (AOUI) di Verona
- Sicily
  - Catania, Sicily, Italy, 95122
    - Recruiting
    - UOC Oncologia Medica, ARNAS GARIBALDI - PRESIDIO OSPEDALIERO NESIMA
- Turin
  - Orbassano, Turin, Italy, 10043
    - Recruiting
    - A.O.U. San Luigi Gonzaga
- Tuscany
  - Florence, Tuscany, Italy, 50134
    - Recruiting
    - SODc Oncologia Medica e Clinica, AOU Careggi
  - Pisa, Tuscany, Italy, 56126
    - Recruiting
    - Azienda Ospedaliero Universitaria Pisana
- Veneto
  - Padova, Veneto, Italy, 35128
    - Recruiting
    - Istituto Oncologico Veneto - IRCCS
Japan
- - Osaka, Japan, 540-0006
    - Recruiting
    - National Hospital Organization Osaka National Hospital
- Chiba
  - Chiba, Chiba, Japan, 260-8717
    - Recruiting
    - Chiba Cancer Center
  - Kashiwa-shi, Chiba, Japan, 277-8577
    - Recruiting
    - National Cancer Center Hospital East
- Ehime
  - Matsuyama, Ehime, Japan, 791-0280
    - Active, not recruiting
    - NHO Shikoku Cancer Center
- Fukuoka
  - Fukuoka, Fukuoka, Japan, 811-1395
    - Recruiting
    - National Hospital Organization Kyushu Cancer Center
- Hokkaido
  - Sapporo, Hokkaido, Japan, 060-8648
    - Recruiting
    - Hokkaido University Hospital
- Hyōgo
  - Kobe, Hyōgo, Japan, 650-0047
    - Recruiting
    - Kobe City Hospital Organization Kobe City Medical Center General Hospital
- Kagawa-ken
  - Kita-gun, Kagawa-ken, Japan, 761-0793
    - Recruiting
    - Kagawa University Hospital
- Kanagawa
  - Kawasaki-shi, Kanagawa, Japan, 216-8511
    - Recruiting
    - St. Marianna University Hospital
  - Yokohama, Kanagawa, Japan, 241-8515
    - Recruiting
    - Kanagawa Cancer Center
- Osaka
  - Osaka, Osaka, Japan, 558-8558
    - Recruiting
    - Osaka General Medical Center
  - Osakasayama-shi, Osaka, Japan, 589-8511
    - Recruiting
    - Kindai University Hospital
  - Sakai, Osaka, Japan, 590-0197
    - Recruiting
    - Kindai University Hospital
  - Suita, Osaka, Japan, 565-0871
    - Recruiting
    - The University of Osaka Hospital
  - Takatsuki-shi, Osaka, Japan, 569-8686
    - Recruiting
    - Osaka Medical and Pharmaceutical University Hospital
- Saitama
  - Kitaadachi-gun, Saitama, Japan, 362-0806
    - Recruiting
    - Saitama Cancer Center
- Tokyo
  - Chuo-Ku, Tokyo, Japan, 104-0045
    - Recruiting
    - National Cancer Center Hospital
  - Koto-ku, Tokyo, Japan, 135-8550
    - Recruiting
    - Cancer Institute Hospital of JFCR
Netherlands
- - Amsterdam, Netherlands, 1066 CX
    - Recruiting
    - Netherlands Cancer Institute
  - Nieuwegein, Netherlands, 3534 CM
    - Recruiting
    - Klinische Farmacie
  - Utrecht, Netherlands, 3543 AZ
    - Recruiting
    - St. Antonius Ziekenhuis - Ziekenhuis Utrecht
  - Venlo, Netherlands, 5912 BL
    - Recruiting
    - VieCuri Medisch Centrum
Norway
- - Bergen, Norway, N0-5053
    - Recruiting
    - Sjukehusapoteket i Bergen [Bergen Hospital Pharmacy]
  - Bergen, Norway, NO-5021
    - Recruiting
    - Helse Bergen HF, Haukeland University Hospital
  - Oslo, Norway, 0379
    - Recruiting
    - Oslo University Hospital (OUH) - The Norwegian Radium Hospital
Poland
- - Lodz, Poland, 91-211
    - Recruiting
    - Salve Medica
  - Lodz, Poland, 91-211
    - Recruiting
    - Salve Medica Apteka Szpitalna
- Greater Poland Voivodeship
  - Konin, Greater Poland Voivodeship, Poland, 62-500
    - Recruiting
    - Przychodnia Lekarska KOMED Roman Karaszewski
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Poland, 02-034
    - Recruiting
    - Narodowy lnstytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy lnstytut Badawczy
  - Warsaw, Masovian Voivodeship, Poland, 02-781
    - Recruiting
    - Marii Sklodowskiej-Curie Panstwowy lnstytut Badawczy
  - Warsaw, Masovian Voivodeship, Poland, 04-141
    - Not yet recruiting
    - Wojskowy Instytut Medyczny Klinika Onkologii
  - Warsaw, Masovian Voivodeship, Poland, 04-141
    - Not yet recruiting
    - Wojskowy Instytut Medyczny
- Podkarpackie Voivodeship
  - Rzeszów, Podkarpackie Voivodeship, Poland, 35-021
    - Not yet recruiting
    - MRUK-MED | Sp. z.o.o Apteka szpitalna
  - Rzeszów, Podkarpackie Voivodeship, Poland, 35-021
    - Not yet recruiting
    - MRUK-MED | Sp. z.o.o
- Pomeranian Voivodeship
  - Gdansk, Pomeranian Voivodeship, Poland, 80-214
    - Recruiting
    - Apteka Szpitalna Uniwersytie Centrum Kliniczne
  - Gdansk, Pomeranian Voivodeship, Poland, 80-214
    - Recruiting
    - Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne.
Portugal
- - Almada, Portugal, 2805-267
    - Recruiting
    - Hospital Garcia de Orta
  - Guarda, Portugal, 6300-035
    - Recruiting
    - Unidade Local de Saude da Guarda-Hospital Sousa Martins
  - Lisbon, Portugal, 1400-038
    - Recruiting
    - Fundacao Champalimaud
  - Porto, Portugal, 4099-001
    - Recruiting
    - Centro Hospitalar Universitário de Santo Antonio,E.P.E.
Slovakia
- - Bratislava, Slovakia, 833 10
    - Recruiting
    - Narodny Onkologicky ustav II.Onkologicka Klinika LFUK a NOU
  - Bratislava, Slovakia, 833 10
    - Recruiting
    - Narodny onkologicky ustav nemocnica lekaren
South Korea
- - Incheon, South Korea, 21565
    - Recruiting
    - Gachon University Gil Medical Center
  - Seoul, South Korea, 05505
    - Recruiting
    - Asan Medical Center
  - Seoul, South Korea, 03080
    - Recruiting
    - Seoul National University Hospital
  - Seoul, South Korea, 03722
    - Recruiting
    - Severance Hospital, Yonsei University Health System
  - Seoul, South Korea, 06351
    - Recruiting
    - Samsung Medical Center
  - Seoul, South Korea, 02841
    - Recruiting
    - Korea University Anam Hospital
  - Seoul, South Korea, 08308
    - Recruiting
    - Korea University Guro Hospital
Spain
- - Alicante, Spain, 03010
    - Recruiting
    - Hospital General Universitario de Alicante
  - Barcelona, Spain, 08036
    - Recruiting
    - Hospital Clinic de Barcelona
  - Barcelona, Spain, 08035
    - Recruiting
    - Hospital Vall d'Hebron
  - Barcelona, Spain, 08029
    - Recruiting
    - Radiology: CETIR Ascires
  - Barcelona, Spain, 08035
    - Recruiting
    - Data review: Vall d'Hebron institute of Oncology (VHIO).
  - Barcelona, Spain, 08035
    - Recruiting
    - Hospital Vall d'Hebron Unidad de Farmacia de Ensayos Clinicos Oncohematologia
  - Córdoba, Spain, 14004
    - Recruiting
    - Hospital Universitario Reina Sofía
  - Lleida, Spain, 25198
    - Recruiting
    - Hospital Universitari Arnau de Vilanova
  - Madrid, Spain, 28034
    - Recruiting
    - Hospital Universitario Ramón y Cajal
  - Madrid, Spain, 28041
    - Recruiting
    - Hospital Universitario 12 de Octubre
  - Madrid, Spain, 28046
    - Recruiting
    - Hospital Universitario La Paz
  - Madrid, Spain, 28007
    - Recruiting
    - Hospital General Universitario Gregorio Marañón
  - Málaga, Spain, 29011
    - Recruiting
    - Hospital Regional Universitario de Málaga (Hospital Civil)
  - Ourense, Spain, 32005,
    - Recruiting
    - Complejo Hospitalario Universitario de Ourense
  - Oviedo, Spain, 33011
    - Recruiting
    - Hospital Universitario Central de Asturias
  - Pamplona, Spain, 31008
    - Recruiting
    - Complejo Hospitalario de Navarra
  - Santander, Spain, 39008
    - Recruiting
    - Hospital Universitario Marqués de Valdecilla
  - Seville, Spain, 41013
    - Recruiting
    - Hospital Universitario Virgen del Rocio
  - Valencia, Spain, 46014
    - Recruiting
    - Hospital General Universitario de Valencia
  - Zaragoza, Spain, 50009
    - Recruiting
    - Hospital Universitario Miguel Servet
  - Zaragoza, Spain, 50006
    - Recruiting
    - Hospital Quiron Salud Zaragoza
- Barcelona
  - L'Hospitalet de Llobregat, Barcelona, Spain, 08908
    - Recruiting
    - Hospital Duran i Reynals - Institut Catala d'Oncologia L'Hospitalet (ICO L'Hospitalet)
- Other
  - Barcelona, Other, Spain, 08029
    - Recruiting
    - CETIR Viladomat
- Santa CRUZ DE Tenerife
  - San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, Spain, 38320
    - Recruiting
    - Complejo Hospitalario Universitario de Canarias
Switzerland
- - Schlieren, Switzerland, 8952
    - Recruiting
    - Zuripharm AG
  - Zurich, Switzerland, 8091
    - Recruiting
    - Universitatsspital Zurich - Klinik fur Medizinische Onkologie und Hamatologie USZ
Taiwan
- - Kaohsiung City, Taiwan, 833, (R.O.C.)
    - Recruiting
    - Kaohsiung Chang Gung Memorial Hospital
  - Tainan, Taiwan, 704, R.O.C.
    - Recruiting
    - National Cheng Kung University Hospital
  - Taipei, Taiwan, 11217
    - Recruiting
    - Taipei Veterans General Hospital
  - Taipei, Taiwan, 100 ROC
    - Recruiting
    - National Taiwan University Hospital
  - Taipei, Taiwan, 10048
    - Recruiting
    - National Taiwan University Hospital Clinical Trial Pharmacy
  - Taoyuan, Taiwan, 333 (R.O.C.)
    - Recruiting
    - Chang Gung Memorial Hospital LinKou
United Kingdom
- - Bristol, United Kingdom, BS2 8ED
    - Recruiting
    - University Hospitals Bristol and Weston NHS Foundation Trust
  - Cambridge, United Kingdom, CB2 0QQ
    - Recruiting
    - Cambridge University Hospitals NHS Foundation Trust, Oncology Centre
  - Leeds, United Kingdom, LS97TF
    - Recruiting
    - Leeds Teaching Hospitals NHS Trust, st James's Institute of Oncology
  - London, United Kingdom, SW3 6JJ
    - Recruiting
    - The Royal Marsden NHS Foundation Trust
  - London, United Kingdom, W12 0NN
    - Recruiting
    - Imperial College Healthcare NHS Trust
  - London, United Kingdom, SE1 9RT
    - Recruiting
    - Guy's and Saint Thomas' NHS Foundation Trust
  - London, United Kingdom, SW3 6JJ
    - Recruiting
    - The Royal Marsden Hospital - Chelsea Site
  - Manchester, United Kingdom, M20 4BX
    - Recruiting
    - The Christie NHS Foundation Trust
  - Newcastle upon Tyne, United Kingdom, NE7 7DN
    - Recruiting
    - The Newcastle upon Tyne Hospitals NHS Foundation Trust
- Chelsea
  - Newcastle upon Tyne, Chelsea, United Kingdom, NE7 7DN
    - Recruiting
    - The Newcastle upon Tyne Hospitals NHS Foundation Trust
- Glasgow CITY
  - Glasgow, Glasgow CITY, United Kingdom, G12 0YN
    - Recruiting
    - NHS Greater Glasgow & Clyde - Beatson West of Scotland Cancer Care
- Surrey
  - Sutton, Surrey, United Kingdom, SM2 5PT
    - Recruiting
    - The Royal Marsden Hospital
United States
- Arizona
  - Glendale, Arizona, United States, 85304
    - Recruiting
    - Palo Verde Hematology Oncology
  - Phoenix, Arizona, United States, 85054
    - Recruiting
    - Mayo Clinic Hospital
  - Phoenix, Arizona, United States, 85054
    - Recruiting
    - Mayo Clinic Building - Phoenix
  - Scottsdale, Arizona, United States, 85259
    - Recruiting
    - Mayo Clinic
- California
  - Anaheim, California, United States, 92806
    - Active, not recruiting
    - Kaiser Permanente Anaheim Kraemer Medical Offices
  - Anaheim, California, United States, 92801
    - Recruiting
    - Los Angeles Cancer Network - Anaheim
  - Baldwin Park, California, United States, 91706
    - Active, not recruiting
    - Kaiser Permanente Baldwin Park Medical Center
  - Bellflower, California, United States, 90706
    - Active, not recruiting
    - Kaiser Permanente Bellflower Medical Offices
  - Fontana, California, United States, 92335
    - Active, not recruiting
    - Kaiser Permanente Fontana Medical Center
  - Fountain Valley, California, United States, 92708
    - Recruiting
    - Los Angeles Cancer Network - Fountain Vally
  - Glendale, California, United States, 91204
    - Recruiting
    - Los Angeles Hematology Oncology Medical Group
  - Glendale, California, United States, 91206
    - Recruiting
    - Los Angeles Hematology Oncology Medical Group
  - Glendale, California, United States, 91204
    - Recruiting
    - Los Angeles Cancer Network - Corporate Office
  - Harbor City, California, United States, 90710
    - Active, not recruiting
    - Kaiser Permanente South Bay Medical Center
  - Irvine, California, United States, 92618
    - Active, not recruiting
    - Kaiser Permanente Alton/Sand Canyon Medical Offices
  - Los Angeles, California, United States, 90017
    - Recruiting
    - Los Angeles Hematology Oncology Medical Group
  - Los Angeles, California, United States, 90027
    - Active, not recruiting
    - Kaiser Permanente Los Angeles Medical Offices
  - Los Angeles, California, United States, 90034
    - Active, not recruiting
    - Kaiser Permanente West Los Angeles Medical Center
  - Los Angeles, California, United States, 90033
    - Terminated
    - University of Southern California
  - Los Angeles, California, United States, 90020
    - Terminated
    - USC Norris Koreatown - Medical Oncology
  - Los Angeles, California, United States, 90033
    - Terminated
    - Keck Hospital of USC
  - Los Angeles, California, United States, 90033
    - Terminated
    - Los Angeles General Medical Center
  - Los Angeles, California, United States, 90033
    - Terminated
    - USC/Norris Comprehensive Cancer Center
  - Newport Beach, California, United States, 92663
    - Terminated
    - USC Norris Oncology/Hematology - Newport Beach
  - Ontario, California, United States, 91761
    - Active, not recruiting
    - Kaiser Permanente Ontario Medical Center
  - Panorama City, California, United States, 91402
    - Active, not recruiting
    - Kaiser Permanente Panorama City Medical Center
  - Pasadena, California, United States, 91105
    - Recruiting
    - Los Angeles Hematology Oncology Medical Group
  - Pasadena, California, United States, 91105
    - Terminated
    - Keck Medical Center of USC Pasadena
  - Riverside, California, United States, 92505
    - Active, not recruiting
    - Kaiser Permanente Riverside Medical Center
  - San Diego, California, United States, 92108
    - Active, not recruiting
    - Kaiser Permanente San Diego Mission Road (Regulatory and Lab Supplies)
  - San Diego, California, United States, 92120
    - Active, not recruiting
    - Kaiser Permanente Zion Medical Center
  - San Marcos, California, United States, 92078
    - Active, not recruiting
    - Kaiser Permanente San Marcos Medical Offices
  - Van Nuys, California, United States, 91405
    - Recruiting
    - Los Angeles Hematology Oncology Medical Group
  - Woodland Hills, California, United States, 91367
    - Active, not recruiting
    - Kaiser Permanente Woodland Hills Medical Center
- Colorado
  - Aurora, Colorado, United States, 80012
    - Recruiting
    - Rocky Mountain Cancer Centers, LLP
  - Boulder, Colorado, United States, 80303
    - Recruiting
    - Rocky Mountain Cancer Centers, LLP
  - Colorado Springs, Colorado, United States, 80907
    - Recruiting
    - Rocky Mountain Cancer Centers, LLP
  - Denver, Colorado, United States, 80218
    - Recruiting
    - Rocky Mountain Cancer Centers, LLP
  - Denver, Colorado, United States, 80220
    - Recruiting
    - Rocky Mountain Cancer Centers, LLP
  - Lakewood, Colorado, United States, 80228
    - Recruiting
    - Rocky Mountain Cancer Centers, LLP
  - Littleton, Colorado, United States, 80120
    - Recruiting
    - Rocky Mountain Cancer Centers, LLP
  - Lone Tree, Colorado, United States, 80124
    - Recruiting
    - Rocky Mountain Cancer Centers, LLP
  - Longmont, Colorado, United States, 80504
    - Recruiting
    - Rocky Mountain Cancer Centers, LLP
  - Pueblo, Colorado, United States, 81003
    - Recruiting
    - Rocky Mountain Cancer Centers, LLP
  - Thornton, Colorado, United States, 80260
    - Recruiting
    - Rocky Mountain Cancer Centers, LLP
- Florida
  - Aventura, Florida, United States, 33180
    - Recruiting
    - Mount Sinai Medical Center Aventura ER
  - Miami Beach, Florida, United States, 33140
    - Recruiting
    - Mount Sinai Medical Center
  - Miami Beach, Florida, United States, 33140
    - Recruiting
    - Mount Sinai Comprehensive Cancer Center
- Georgia
  - Atlanta, Georgia, United States, 30308
    - Recruiting
    - Emory University Hospital Midtown
  - Atlanta, Georgia, United States, 30342
    - Recruiting
    - Emory Saint Joseph's Hospital
  - Atlanta, Georgia, United States, 30322
    - Recruiting
    - Emory University Hospital
  - Atlanta, Georgia, United States, 30322
    - Recruiting
    - Winship Cancer Institute
- Kansas
  - Merriam, Kansas, United States, 66204
    - Terminated
    - Alliance for Multispecialty Research LLC.
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Recruiting
    - Norton Cancer Institute, Downtown
  - Louisville, Kentucky, United States, 40217
    - Recruiting
    - Norton Audubon Hospital
  - Louisville, Kentucky, United States, 40241
    - Recruiting
    - Norton Brownsboro Hospital
  - Louisville, Kentucky, United States, 40202
    - Recruiting
    - Norton Cancer Institute - Downtown
  - Louisville, Kentucky, United States, 40241
    - Recruiting
    - Norton Cancer Institute, Brownsboro Hospital Campus
  - Louisville, Kentucky, United States, 40202
    - Recruiting
    - Norton Hospital
  - Louisville, Kentucky, United States, 40217
    - Recruiting
    - Norton Cancer Institute, Audubon Hospital Campus
- Minnesota
  - Burnsville, Minnesota, United States, 55337
    - Recruiting
    - Minnesota Oncology Hematology, Pa
  - Coon Rapids, Minnesota, United States, 55433
    - Recruiting
    - Allina Health Cancer Institute
  - Coon Rapids, Minnesota, United States, 55433
    - Recruiting
    - Minnesota Oncology Hematology, Pa
  - Edina, Minnesota, United States, 55435
    - Recruiting
    - M Health Fairview Cancer Clinic-Edina
  - Edina, Minnesota, United States, 55435
    - Recruiting
    - Minnesota Oncology Hematology, Pa
  - Fridley, Minnesota, United States, 55432
    - Recruiting
    - Minnesota Oncology Hematology, Pa
  - Maple Grove, Minnesota, United States, 55369
    - Recruiting
    - Minnesota Oncology Hematology, Pa
  - Maplewood, Minnesota, United States, 55109
    - Recruiting
    - M Health Fairview St. John's Hospital
  - Maplewood, Minnesota, United States, 55109
    - Recruiting
    - Minnesota Oncology Hematology, Pa
  - Minneapolis, Minnesota, United States, 55415
    - Recruiting
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, United States, 55404
    - Recruiting
    - Allina Health Cancer Institute (Virginia Piper Cancer Institute)
  - Minneapolis, Minnesota, United States, 55404
    - Recruiting
    - Minnesota Oncology Hematology, Pa
  - Robbinsdale, Minnesota, United States, 55422
    - Recruiting
    - North Memorial Health Cancer Center
  - Rochester, Minnesota, United States, 55905
    - Recruiting
    - Mayo Clinic Cancer Center Outpatient Pharmacy
  - Saint Louis Park, Minnesota, United States, 55416
    - Recruiting
    - Metro Minnesota Community Oncology Research Consortium
  - Saint Louis Park, Minnesota, United States, 55426
    - Recruiting
    - Park Nicollet Frauenshuh Cancer Center
  - Saint Louis Park, Minnesota, United States, 55426
    - Recruiting
    - Regulatory Location: MMCORC
  - Saint Paul, Minnesota, United States, 55101
    - Recruiting
    - Regions Hospital
  - Saint Paul, Minnesota, United States, 55102
    - Recruiting
    - Allina Health Cancer Institute-United(VPCI)
  - Woodbury, Minnesota, United States, 55125
    - Recruiting
    - Minnesota Oncology Hematology, PA Cornerstone Medical Specialty Center
- New Jersey
  - Basking Ridge, New Jersey, United States, 07920
    - Recruiting
    - MSK Basking Ridge
  - Middletown, New Jersey, United States, 07748
    - Recruiting
    - MSK Monmouth
  - Montvale, New Jersey, United States, 07645
    - Recruiting
    - MSK Bergen
- New York
  - Commack, New York, United States, 11725
    - Recruiting
    - MSK Commack
  - Harrison, New York, United States, 10604
    - Recruiting
    - MSK Westchester
  - New York, New York, United States, 10022
    - Recruiting
    - Rockefeller Outpatient Pavilion (53rd Street)
  - New York, New York, United States, 10065
    - Recruiting
    - Memorial Solan Kettering Cancer Center- Main Campus
  - Uniondale, New York, United States, 11553
    - Recruiting
    - MSK Nassau
- North Carolina
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Duke University Medical Center
    - Principal Investigator:
      
      John H Strickler
    - Contact:
      
      Brooke Currier
      
      Email: grayson.currier@duke.edu
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Duke University Hospital
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Duke University Medical Center, Duke Cancer Center
  - Pinehurst, North Carolina, United States, 28374
    - Recruiting
    - Firsthealth Moore Regional Hospital
  - Pinehurst, North Carolina, United States, 28374
    - Recruiting
    - FirstHealth Cancer Center
- Ohio
  - Canton, Ohio, United States, 44718
    - Terminated
    - Gabrail Cancer Center Research
- Oregon
  - Happy Valley, Oregon, United States, 97015
    - Recruiting
    - Northwest Cancer Specialists, P.C
  - Newberg, Oregon, United States, 97132
    - Recruiting
    - Providence Cancer Institute Newberg Clinic
  - Oregon City, Oregon, United States, 97045
    - Recruiting
    - Providence Cancer Institute Willamette Falls Clinic
  - Portland, Oregon, United States, 97213
    - Recruiting
    - Providence Portland Medical Center
    - Contact:
      
      Mary McCormick
      
      Phone Number: 503-216-3116
      
      Email: Mary.McCormick@Providence.org
    - Principal Investigator:
      
      Evthokia Hobbs
    - Principal Investigator:
      
      Kelly S Perlewitz
  - Portland, Oregon, United States, 97225
    - Recruiting
    - Providence St. Vincent Medical Center
  - Portland, Oregon, United States, 97213
    - Recruiting
    - Providence Cancer Institute Franz Clinic
  - Portland, Oregon, United States, 97225
    - Recruiting
    - Providence Oncology and Hematology Care Clinic - Westside
  - Portland, Oregon, United States, 97227
    - Recruiting
    - Northwest Cancer Specialists, P.C.
  - Portland, Oregon, United States, 97225
    - Recruiting
    - Providence St. Vincent Medical Center- Investigational Drug Services
  - Portland, Oregon, United States, 97225
    - Recruiting
    - Providence Portland Medical Center-Westside
  - Tigard, Oregon, United States, 97223
    - Recruiting
    - Northwest Cancer Specialists, P.C.
- Pennsylvania
  - Beaver, Pennsylvania, United States, 15009
    - Recruiting
    - UPMC Hillman Cancer Center - Beaver
  - Butler, Pennsylvania, United States, 16001
    - Recruiting
    - UPMC Hillman Cancer Center at Butler Health System
  - Erie, Pennsylvania, United States, 16505
    - Recruiting
    - UPMC Hillman Cancer Center Erie
  - Greensburg, Pennsylvania, United States, 15601
    - Recruiting
    - UPMC Hillman Cancer Center at Arnold Palmer Pavilion, In Partnership with Excela Health
  - Harrisburg, Pennsylvania, United States, 17109
    - Recruiting
    - UPMC Hillman Cancer Center - Pinnacle (Community Osteopathic / Medical Sciences Pavillion)
  - Irwin, Pennsylvania, United States, 15642
    - Recruiting
    - UPMC Hillman Cancer Center at Arnold Palmer Pavilion, In Partnership with Excela Health
  - Mechanicsburg, Pennsylvania, United States, 17050
    - Recruiting
    - UPMC Hillman Cancer Center - Pinnacle (Ortenzio)
  - Monroeville, Pennsylvania, United States, 15146
    - Recruiting
    - UPMC Hillman Cancer Center - Monroeville
  - Pittsburgh, Pennsylvania, United States, 15232
    - Recruiting
    - UPMC Hillman Cancer Center
  - Pittsburgh, Pennsylvania, United States, 15215
    - Recruiting
    - UPMC Hillman Cancer Center - St Margarets
  - Pittsburgh, Pennsylvania, United States, 15237
    - Recruiting
    - UPMC Hillman Cancer Center - Passavant (HOA)
  - Pittsburgh, Pennsylvania, United States, 15243
    - Recruiting
    - St. Clair Cancer Center Medical Oncology
  - Washington, Pennsylvania, United States, 15301
    - Recruiting
    - UPMC Hillman Cancer Center - Washington
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Recruiting
    - Avera Cancer Institute
    - Contact:
      
      Heidi Nickles
      
      Phone Number: 605-322-3295
      
      Email: heidi.nickles@avera.org
    - Principal Investigator:
      
      Heidi McKean
- Tennessee
  - Nashville, Tennessee, United States, 37232
    - Recruiting
    - Henry-Joyce Cancer Clinic
- Texas
  - Dallas, Texas, United States, 75246
    - Recruiting
    - Texas Oncology - DFW
  - Houston, Texas, United States, 77030
    - Recruiting
    - The University of Texas MD Anderson Cancer Center
  - Irving, Texas, United States, 75063
    - Recruiting
    - US Oncology Investigational Products Center (IPC)
  - Irving, Texas, United States, 75063
    - Recruiting
    - US Oncology Investigational Product Center (IPC)
- Virginia
  - Blacksburg, Virginia, United States, 24060
    - Recruiting
    - Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care
  - Low Moor, Virginia, United States, 24457
    - Recruiting
    - Oncology & Hematology Associates of Southwest Virginia
  - Roanoke, Virginia, United States, 24014
    - Recruiting
    - Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care
    - Principal Investigator:
      
      Mark Kochenderfer
    - Contact:
      
      Natasha R Holt
      
      Phone Number: 540-808-1704
      
      Email: natasha.holt@usoncology.com
  - Salem, Virginia, United States, 24153
    - Recruiting
    - Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care
  - Wytheville, Virginia, United States, 24382
    - Recruiting
    - Oncology & Hematology Associates of Southwest Virginia
- Washington
  - Everett, Washington, United States, 98201
    - Recruiting
    - Providence Regional Cancer Partnership
  - Everett, Washington, United States, 98201
    - Recruiting
    - Providence Regional Medical Center Everett
    - Principal Investigator:
      
      Amir Mehrvarz Sarshekeh, MD
  - Vancouver, Washington, United States, 98684
    - Recruiting
    - Northwest Cancer Specialists, P.C.
    - Contact:
      
      Susan R Papenfuse
      
      Phone Number: 360-449-6521
      
      Email: susan.papenfuse@usoncology.com
    - Principal Investigator:
      
      David Cosgrove

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum which is locally advanced unresectable or metastatic
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. 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 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 locally advanced unresectable or 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 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
Active or untreated gastrointestinal (GI) perforation at the time of screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tucatinib Arm Tucatinib + trastuzumab + mFOLFOX6	Drug: tucatinib 300mg given by mouth (orally) twice daily Other Names: TUKYSA, ONT-380, ARRY-380, PF-07265792 Drug: trastuzumab 8mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 day 1, followed by 6mg/kg given by IV every 3 weeks thereafter. Other Names: Herceptin Drug: oxaliplatin 85mg/m2 given by IV every 2 weeks. Component of mFOLFOX6. Drug: leucovorin 400mg/ m2 given by IV every 2 weeks. Component of mFOLFOX6. Drug: levoleucovorin 200mg/ m2 given by IV every 2 weeks. May be given in place of leucovorin. Component of mFOLFOX6. Drug: fluorouracil 400mg/m2 given by IV bolus then 2400mg/m2 given by continuous IV infusion (over 46-48 hours) every 2 weeks. Component of mFOLFOX6.
Active Comparator: Standard of Care Arm Either (1) mFOLFOX6, (2) mFOLFOX6 and bevacizumab, or (3) mFOLFOX6 and cetuximab	Drug: oxaliplatin 85mg/m2 given by IV every 2 weeks. Component of mFOLFOX6. Drug: leucovorin 400mg/ m2 given by IV every 2 weeks. Component of mFOLFOX6. Drug: levoleucovorin 200mg/ m2 given by IV every 2 weeks. May be given in place of leucovorin. Component of mFOLFOX6. Drug: fluorouracil 400mg/m2 given by IV bolus then 2400mg/m2 given by continuous IV infusion (over 46-48 hours) every 2 weeks. Component of mFOLFOX6. Drug: bevacizumab 5mg/kg given by IV every 2 weeks Other Names: Avastin Drug: cetuximab 400mg/m2 loading dose will be given by IV on Cycle 1 day 1, followed by 250mg/m2 given by IV weekly Other Names: Erbitux

Participant Group / Arm

Intervention / Treatment

Experimental: Tucatinib Arm

Tucatinib + trastuzumab + mFOLFOX6

Drug: tucatinib

300mg given by mouth (orally) twice daily

Other Names:

TUKYSA, ONT-380, ARRY-380, PF-07265792

Drug: trastuzumab

8mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 day 1, followed by 6mg/kg given by IV every 3 weeks thereafter.

Other Names:

Herceptin

Drug: oxaliplatin

85mg/m2 given by IV every 2 weeks. Component of mFOLFOX6.

Drug: leucovorin

400mg/ m2 given by IV every 2 weeks. Component of mFOLFOX6.

Drug: levoleucovorin

200mg/ m2 given by IV every 2 weeks. May be given in place of leucovorin. Component of mFOLFOX6.

Drug: fluorouracil

400mg/m2 given by IV bolus then 2400mg/m2 given by continuous IV infusion (over 46-48 hours) every 2 weeks. Component of mFOLFOX6.

Active Comparator: Standard of Care Arm

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

Drug: oxaliplatin

85mg/m2 given by IV every 2 weeks. Component of mFOLFOX6.

Drug: leucovorin

400mg/ m2 given by IV every 2 weeks. Component of mFOLFOX6.

Drug: levoleucovorin

200mg/ m2 given by IV every 2 weeks. May be given in place of leucovorin. Component of mFOLFOX6.

Drug: fluorouracil

400mg/m2 given by IV bolus then 2400mg/m2 given by continuous IV infusion (over 46-48 hours) every 2 weeks. Component of mFOLFOX6.

Drug: bevacizumab

5mg/kg given by IV every 2 weeks

Other Names:

Avastin

Drug: cetuximab

400mg/m2 loading dose will be given by IV on Cycle 1 day 1, followed by 250mg/m2 given by IV weekly

Other Names:

Erbitux

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR) Time Frame: Up to approximately 3 years	The time from the date of randomization to the BICR assessment of disease progression according to RECIST v1.1 or death from any cause	Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS) Time Frame: Up to approximately 6 years	The time from randomization to death from any cause	Up to approximately 6 years
PFS per RECIST v1.1 by investigator assessment Time Frame: Up to approximately 3 years	The time from the date of randomization to the investigator assessment of disease progression according to RECIST v1.1 or death from any cause	Up to approximately 3 years
Duration of response (DOR) per RECIST v1.1 by BICR Time Frame: Up to approximately 3 years	The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of disease progression per RECIST v1.1 or death from any cause	Up to approximately 3 years
DOR per RECIST v1.1 by investigator assessment Time Frame: Up to approximately 3 years	The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of disease progression per RECIST v1.1 or death from any cause	Up to approximately 3 years
Time to second progression or death (PFS2) Time Frame: Up to approximately 3 years	The time from randomization to disease progression on the next-line of therapy, or death from any cause	Up to approximately 3 years
Incidence of adverse events (AEs) Time Frame: Through 30 days after the last study treatment; approximately 1 year	Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.	Through 30 days after the last study treatment; approximately 1 year
Incidence of dose alterations Time Frame: Through 30 days after the last study treatment; approximately 1 year		Through 30 days after the last study treatment; approximately 1 year
Trough concentration (Ctrough) Time Frame: Approximately 4 months	PK parameter	Approximately 4 months
Confirmed objective response rate (cORR) per RECIST v1.1 by BICR Time Frame: Up to approximately 3 years	The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1, as assessed by BICR	Up to approximately 3 years
cORR per RECIST v1.1 by investigator assessment Time Frame: Up to approximately 3 years	The proportion of participants with confirmed CR or PR according to RECIST v1.1, as assessed by investigators	Up to approximately 3 years
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQC30) score Time Frame: Through 30-37 days after the last study treatment; approximately 1 year	Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/quality of life (QoL) scales, higher scores indicate better functioning or global health status/quality of life (QoL). For symptom scales, higher scores indicate greater symptom burden.	Through 30-37 days after the last study treatment; approximately 1 year
Time to meaningful change in EORTC QLQ30 score Time Frame: Through 30-37 days after the last study treatment; approximately 1 year	The time from baseline to the first onset of a ≥10-point changes in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.	Through 30-37 days after the last study treatment; approximately 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Collaborators

Merck Sharp & Dohme LLC

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

July 3, 2030

Study Registration Dates

First Submitted

February 14, 2022

First Submitted That Met QC Criteria

February 14, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Actual)

July 22, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

SGNTUC-029
C4251008 (Other Identifier: Alias Study Number)
2024-514180-25-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer (MOUNTAINEER-03)

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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product