Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer (BEACON CRC)

December 1, 2023 updated by: Pfizer

A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer

This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib + binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study.

Study Overview

Status

Completed

Conditions

BRAF V600E-mutant Metastatic Colorectal Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

702

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 Locations

Argentina
- - Cordoba, Argentina, X5004FHP
    - Clínica Universitaria Reina Fabiola
  - La Rioja, Argentina, 5300
    - Centro Oncologico Riojano Integral - CORI
- Buenos Aires
  - Pergamino, Buenos Aires, Argentina, 2700
    - CLINICA PERGAMINO S.A. (Centro de Investigacion Pergamino S.A.)
- LA Pampa
  - Santa Rosa, LA Pampa, Argentina, L6300EAN
    - Centro Medico INFINITO
- Tucumán
  - San Miguel de Tucumán, Tucumán, Argentina, T4000GTB
    - Centro Medico CAIPO (Centro para la Atención del paciente Oncológico)
Australia
- NEW South Wales (nsw)
  - Darlinghurst, NEW South Wales (nsw), Australia, 2010
    - St Vincent's Clinic
  - Darlinghurst, NEW South Wales (nsw), Australia, 2010
    - St Vincent's Hospital Sydney
  - Parramatta, NEW South Wales (nsw), Australia, 2150
    - Marsden Eye Specialists
  - Sydney, NEW South Wales (nsw), Australia, 2300
    - Newcastle Eye Centre
- Queensland
  - South Brisbane, Queensland, Australia, 4101
    - Mater Misericordiae Limited
- South Australia
  - Adelaide, South Australia, Australia, 5000
    - Central Adelaide Local Health Network Inc. operating as Royal Adelaide Hospital
  - Bedford Park, South Australia, Australia, 5042
    - Flinders Medical Centre
  - Woodville South, South Australia, Australia, 5011
    - Central Adelaide Local Health Network Inc. operating as The Queen Elizabeth Hospital
- Victoria
  - Clayton, Victoria, Australia, 3168
    - Monash Health Translation Precinct - Monash Health
  - Heidelberg, Victoria, Australia, 3084
    - Austin Health
  - Melbourne, Victoria, Australia, 3000
    - Peter MacCallum Cancer Centre
Austria
- - Wien, Austria, 1090
    - AKH Wien
  - Wien, Austria, 1010
    - DZU, Diagnose Zentrum Urania GmbH
  - Wien, Austria, 1090
    - Medizinische Universitaet Wien/AKH Wien
  - Wien, Austria, 1090
    - Medizinische Universität Wien/AKH Wien
- Oberoesterreich
  - Wels, Oberoesterreich, Austria, 4600
    - Klinikum Wels - Grieskirchen GmbH, Abteilung fuer Innere Medizin IV
  - Wels, Oberoesterreich, Austria, 4600
    - Klinikum Wels-Grieskirchen GmbH, Abteilung fuer Augenheilkunde und Optometrie
  - Wels, Oberoesterreich, Austria, 4600
    - Klinikum Wels-Grieskirchen GmbH, Abteilung fuer Innere Medizin II
  - Wels, Oberoesterreich, Austria, 4600
    - Klinikum Wels-Grieskirchen GmbH, Institut fuer Nuklearmedizin
  - Wels, Oberoesterreich, Austria, 4600
    - Klinikum Wels-Grieskirchen GmbH, Institut fuer Radiologie I
Belgium
- - Bonheiden, Belgium, 2820
    - Imelda Ziekenhuis
  - Charleroi, Belgium, 6000
    - Grand Hôpital de Charleroi (GHdC)
  - Edegem, Belgium, 2650
    - UZ Antwerpen
  - Gent, Belgium, 9000
    - AZ Maria Middelares
  - Leuven, Belgium, 3000
    - University Hospital Gasthuisberg (UZ Leuven)
  - Liege, Belgium, 4000
    - Centre Hospitalier Universitaire (Chu) de Liege
  - Liege, Belgium, 4000
    - CHC Saint Joseph
  - Roeselaere, Belgium, 8800
    - AZ Delta Roeselaere-Menen
  - Verviers, Belgium, 4800
    - Centre Hospitalier Regional (CHR) - Verviers
- Luxembourg
  - Libramont-Chevigny, Luxembourg, Belgium, 6800
    - Centre Hospitalier de l'Ardenne - Site de Libramont
- WEST Vlaanderen
  - Brugge, WEST Vlaanderen, Belgium, 8000
    - AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology
Brazil
- - São Paulo, Brazil, 01236-030
    - Instituto de Ensino e Pesquisa São Lucas
  - São Paulo, Brazil, 01242-020
    - Instituto de Ensino e Pesquisa São Lucas - Pharmacy
  - São Paulo, Brazil, 01507-000
    - Hospital Leforte
  - São Paulo, Brazil, 04038-020
    - IPEPO - Instituto da visão
- Bahia
  - Salvador, Bahia, Brazil, 41820-020
    - Hospital do Olho
  - Salvador, Bahia, Brazil, 41820-021
    - CENOB - Centro de Oncologia da Bahia SS Ltda / Oncovida
- ES
  - Cachoeiro de Itapemirim, ES, Brazil, 29300-045
    - CEMES Centro Medico Especializado em Oftalmologia
  - Cachoeiro de Itapemirim, ES, Brazil, 29308-014
    - Centro de Pesquisas Clínicas em Oncologia
  - Cachoeiro de Itapemirim, ES, Brazil, 29308-055
    - Hospital Evangelico de Cachoeiro de Itapemirim
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brazil, 30110-921
    - Instituto Vizibelli
  - Belo Horizonte, Minas Gerais, Brazil, 30130-090
    - CENANTRON - Centro Avancado de Tratamento Oncologic
- RS
  - Caxias do Sul, RS, Brazil, 95070-560
    - Fundação Universidade de Caxias do Sul
  - Lajeado, RS, Brazil, 95900-000
    - Daniel Lubisco Pandolfi
  - Lajeado, RS, Brazil, 95900-000
    - Sociedade Beneficencia e Cardade de Lajeado/Hospital Bruno Born
  - Lajeado, RS, Brazil, 95900-010
    - Sociedade Beneficencia e Cardade de Lajeado/Hospital Bruno Born
  - Passo Fundo, RS, Brazil, 99010-090
    - Hospital Sao Vicente de Paulo
  - Passo Fundo, RS, Brazil, 99010-080
    - Associacao Hospitalar Beneficente Sao Vicente de Paulo / Hospital Sao Vicente de Paulo
  - Passo Fundo, RS, Brazil, 99010-080
    - Consultorio Medico de Oftalmologia - Dr. Ricardo Tres
  - Pelotas, RS, Brazil, 96010-140
    - Thiago Vernetti Ferreira
  - Pelotas, RS, Brazil, 96015-280
    - Leandro Becker
  - Pelotas, RS, Brazil, 96020-080
    - Fernanda Mendes
  - Pelotas, RS, Brazil, 96020-080
    - UPCO - Unidade de Pesquisas Clínicas em Oncologia
  - Pelotas, RS, Brazil, 96020-260
    - Fernanda Lauermann
  - Porto Alegre, RS, Brazil, 90880-480
    - Hospital Mãe de Deus
  - Porto Alegre, RS, Brazil, 90020-013
    - Diogo Duarte Torre
  - Porto Alegre, RS, Brazil, 90020-090
    - Farmacia Central da Irmandade da Santa Casa de Misericordia de Porto Alegre
  - Porto Alegre, RS, Brazil, 90020-090
    - Irmandade Da Santa Casa de Misericordia de Porto Alegre
  - Porto Alegre, RS, Brazil, 90050-170
    - Nucleo de Novos Tratamentos em Cancer
  - Porto Alegre, RS, Brazil, 90110-270
    - Centro de Pesquisa Clínica de Oncologia e Hematologia - Hospital Mãe de Deus/AESC
  - Porto Alegre, RS, Brazil, 90470-340
    - Clinica de Oftalmologia Lavinsky
- SAO Paulo
  - Barretos, SAO Paulo, Brazil, 14780-110
    - Clinica Toller
  - Barretos, SAO Paulo, Brazil, 14780-300
    - Olhos Centro Diagnostico e Laser LTDA
  - Barretos, SAO Paulo, Brazil, 14784-400
    - Fundação PIO XII
- SC
  - Itajai, SC, Brazil, 88301-220
    - Giuliano Santos Borges - ME / Clinica de Neoplasias Litoral - Centro de Novos Tratamentos Itajai
- SP
  - Santo Andre, SP, Brazil, 09060-870
    - Fundacao do ABC - Faculdade de Medicina do ABC
  - Santo Andre, SP, Brazil, 09060-650
    - Fundacao do ABC - Faculdade de Medicina do ABC
  - Sao Jose do Rio Preto, SP, Brazil, 15090-000
    - Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
  - Sorocaba, SP, Brazil, 18030-075
    - CEPOS - Centro de Estudos e Pesquisas Oncologicas de Sorocaba
  - Sorocaba, SP, Brazil, 18030-200
    - Instituto de Oncologia de Sorocaba "Dr. Gilson Delgado"
  - Sorocaba, SP, Brazil, 18040-425
    - Karen Miyuki Kubokawa Shorer
  - Sorocaba, SP, Brazil, 18047-620
    - Oftalmologia Diagnostica de Sorocaba (ODS)
Canada
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 3N9
    - Eye Care Centre, Vancouver General Hospital
  - Vancouver, British Columbia, Canada, V5Z 4E6
    - BC Cancer, Vancouver Center
- Ontario
  - Ottawa, Ontario, Canada, K1H 8L6
    - The Ottawa Hospital Cancer Centre
  - Toronto, Ontario, Canada, M5G 1X5
    - Mount Sinai Hospital
  - Toronto, Ontario, Canada, M4N 3M5
    - Sunnybrook Research Institute
- Quebec
  - Montreal, Quebec, Canada, H3T 1M5
    - Centre integre universitaire de sante et de services sociaux de l'Ouest-de-l'Ile-de-Montreal
Chile
- Region DE LA Araucania
  - Temuco, Region DE LA Araucania, Chile, 4810469
    - Instituto Clinico Oncologico del Sur (ICOS)
- V Region Valparaiso
  - Vina del Mar, V Region Valparaiso, Chile, 2520612
    - Hospital Clínico Viña del Mar
Czechia
- - Brno, Czechia, 656 53
    - Masarykuv onkologicky ustav
  - Brno, Czechia, 603 00
    - Ocni ordinace Oftalpro s.r.o.
  - Hradec Kralove, Czechia, 500 05
    - Fakultni nemocnice Hradec Kralove
  - Hradec Kralove, Czechia, 500 05
    - Fingerlanduv ustav patologie
  - Hradec Kralove, Czechia, 500 05
    - I. interni kardioangiologicka klinika
  - Hradec Kralove, Czechia, 500 05
    - Klinika nemoci koznich a pohlavnich
  - Hradec Kralove, Czechia, 500 05
    - Nemocnicni lekarna - Usek klinickych studii
  - Hradec Kralove, Czechia, 500 05
    - Ocni klinika
  - Hradec Kralove, Czechia, 500 05
    - Radiologicka klinika
  - Olomouc, Czechia, 779 00
    - Fakultni Nemocnice Olomouc
  - Olomouc, Czechia, 779 00
    - Fakultni nemocnice Olomouc, I. interni klinika - kardiologicka
  - Olomouc, Czechia, 779 00
    - Fakultni nemocnice Olomouc, Lekarna
Denmark
- - Odense C, Denmark, DK-5000
    - Odense University Hospital (OUH)
France
- - BREST Cedex, France, 29609
    - CHU Morvan
  - Besancon Cedex, France, 25030
    - Hôpital Jean Minjoz
  - Ecully, France, 69130
    - Centre Ophtalmologique - Pole Vision - Clinique Val d'Ouest
  - Lyon Cedex 08, France, 69373
    - Centre Léon Bérard
  - Montpellier Cedex 5, France, 34298
    - ICM Val d'Aurelle
  - Nantes Cedex, France, 44093
    - CHU Hôtel-Dieu
  - Paris, France, 75015
    - Hopital Georges Pompidou
  - Paris Cedex 12, France, 75571
    - Centre hospitalier National d'Ophtalmologie des Quinze-Vingts
  - Paris Cedex 12, France, 75571
    - Centre Hospitalier National d'Opthalmologie des Quinze-Vingts (CHNO des XV-XX)
  - Reims Cedex, France, 51092
    - CHU Robert Debré
  - Saint Jeand De Vedas, France, 34430
    - SCM Centre d'ophtalmologie
  - Toulouse, France, 31057
    - CHU Toulouse - Purpan, hopital Pierre-Paul Riquet
  - Toulouse Cedex 9, France, 31059
    - CHU Toulouse-Institut Inuversitaire du Cancer Toulouse
  - Toulouse Cedex 9, France, 31059
    - CHU Toulouse-Rangueil
  - Villejuif Cedex, France, 94805
    - Gustave Roussy
Germany
- - Berlin, Germany, 13589
    - Evangelisches Waldkrankenhaus Spandau
  - Dresden, Germany, 01307
    - Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
  - Hamburg, Germany, 20249
    - Facharztzentrum Eppendorf
  - Hamburg, Germany, 20246
    - Universitaetsklinikum Hamburg Eppendorf, Klinik fuer Augenheilkunde
  - Hamburg, Germany, 20251
    - Universitaetsklinikum Hamburg Eppendorf, Zentrum fuer Radiologie und Endoskopie
  - Hamburg, Germany, 22045
    - ZytoService Deutschland GmbH, Standort-Hamburg-Jenfeld
  - Hamburg, Germany, 22297
    - HKS Kardiologische Praxis am Israelitischen Krankenhaus
  - Hamburg, Germany, 22297
    - Radiologie im Israelitischen Krankenhaus
- Baden-wuerttemberg
  - Tuebingen, Baden-wuerttemberg, Germany, 72076
    - Universitaetsklinikum Tuebingen
  - Ulm, Baden-wuerttemberg, Germany, 89081
    - Universitaetsklinikum Ulm
- Bayern
  - Muenchen, Bayern, Germany, 80336
    - Augenklinik der Universitaet Muenchen
  - Muenchen, Bayern, Germany, 81377
    - LMU Klinikum der Universitaet Muenchen, Campus Grosshadern
- Brandenburg
  - Falkensee, Brandenburg, Germany, 14612
    - Augenarzt-Gemeinschaftspraxis Dr.med.Andreas Kind & Dr.med. Ute Kariger-Schweigert
- Niedersachsen
  - Hannover, Niedersachsen, Germany, 30625
    - Medizinische Hochschule Hannover
  - Hannover, Niedersachsen, Germany, 30625
    - Medizinische Hochschule Hannover (MHH)
- Nordrhein-westfalen
  - Essen, Nordrhein-westfalen, Germany, 35136
    - Kliniken Essen Mitte / Knappschaftskrankenhaus
  - Essen, Nordrhein-westfalen, Germany, 45131
    - Praxis fuer Augenheilkunde Dr. Edmund Meyer-Schwickerath
  - Essen, Nordrhein-westfalen, Germany, 45136
    - Kliniken Essen-Mitte
  - Essen, Nordrhein-westfalen, Germany, 45147
    - Universitaetsklinikum Essen (AoeR), Innere Klinik (Tumorforschung), Westdeutsches Tumorzentrum
  - Essen, Nordrhein-westfalen, Germany, 45147
    - Universitaetsklinikum Essen; Diagnostischeu. Interventionelle Radiologie u. Neuroradiologie
  - Essen, Nordrhein-westfalen, Germany, 45147
    - Universitaetsklinikum Essen; Nuklearmedizin
  - Essen, Nordrhein-westfalen, Germany, 45147
    - Universitaetsklinikum Essen; Zentralapotheke
  - Essen, Nordrhein-westfalen, Germany, 45239
    - Evang. Krankenhaus Essen - Werden; Klinik fuer Augenheilkunde
  - Essen, Nordrhein-westfalen, Germany, 45276
    - Kliniken Essen Mitte / Knappschaftskrankenhaus
  - Moenchengladbach, Nordrhein-westfalen, Germany, 41063
    - Augentagesklinik Maria-Hilf Krankenhaus
  - Moenchengladbach, Nordrhein-westfalen, Germany, 41063
    - Kliniken Maria Hilf GmbH - Franziskuskrankenhaus
  - Moenchengladbach, Nordrhein-westfalen, Germany, 41063
    - Kliniken Maria Hilf GmbH; Klinik fuer Radiologie
  - Neuss, Nordrhein-westfalen, Germany, 41464
    - Lukaskrankenhaus Neuss; Zentrale Apotheke
- North Rhine Westfalia
  - Bochum, North Rhine Westfalia, Germany, 44789
    - Institut f. Pathologie - Ruhr-Universitaet Bochum, Prof. Dr. med. Andrea Tannapfel
- Rheinland-pfalz
  - Worms, Rheinland-pfalz, Germany, 67547
    - Augenarzt Praxis Dr. med. Petra Huelsmann
  - Worms, Rheinland-pfalz, Germany, 67547
    - Gemeinschaftspraxis fuer Radiologie und Nuklearmedizin, Standort Worms
  - Worms, Rheinland-pfalz, Germany, 67547
    - Martin Apotheke
  - Worms, Rheinland-pfalz, Germany, 67547
    - Onkologische Schwerpunktpraxis Worms
  - Worms, Rheinland-pfalz, Germany, 67547
    - Praxisgemeinschaft Kruse + Hofstaetter
Hungary
- - Budapest, Hungary, 1062
    - Magyar Honvedseg Egeszsegugyi Kozpont
  - Budapest, Hungary, 1145
    - Uzsoki Utcai Kórház
  - Budapest, Hungary, 1032
    - Szent Margit Kórház
  - Budapest, Hungary, 1097
    - Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet
  - Budapest, Hungary, 1062
    - Eszak-Pesti Centrumkorhaz-Honvedkorhaz
  - Debrecen, Hungary, 4032
    - Debreceni Egyetem Klinikai Kozpont
  - Pecs, Hungary, 7624
    - Pecsi Tudomanyegyetem Klinikai Kozpont
  - Pecs, Hungary, 7624
    - Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar
- Zala
  - Zalaegerszeg, Zala, Hungary, H-8900
    - Zala Megyei Szent Rafael Korhaz - Onkologiai Osztaly
Israel
- - Ashkelon, Israel, 7830604
    - The Barzilai Medical Center - Oncology Institute
  - Be'er-Sheva, Israel, 8410101
    - Soroka University Medical Center
  - Bnei Brak, Israel, 5126413
    - MOR Institute
  - Jerusalem, Israel, 9112001
    - Ein-Karem Department of Medical Imaging of Hadassah Medical Organization, Hadassah Medical Center,
  - Jerusalem, Israel, 9112001
    - Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem
  - Jerusalem, Israel, 9112001
    - Pharmacy of Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem
  - Jerusalem, Israel, 91240
    - Mt. Scopus Department of Medical Imaging of Hadassah Medical Organization,
  - Kfar Saba, Israel, 4428164
    - Meir Medical Center
  - Kfar Saba, Israel, 4428164
    - Imaging Department of Meir Medical Center
  - Petah Tikva, Israel, 4941492
    - Rabin Medical Center, Beilinson Hospital
  - Petah Tikva, Israel, 4941492
    - Pharmacy of Rabin Medical Center, Beilinson Hospital
  - Tel-Hashomer, Israel, 5262100
    - The Chaim Sheba Medical Center
- NAP
  - Tel-Aviv, NAP, Israel, 6423906
    - Tel Aviv Sourasky Medical Center - Oncology
Italy
- - Bologna, Italy, 40138
    - Policlinico S.Orsola Malpighi, AOU di Bologna - Oncologia Medica
  - Cagliari, Italy, 09124
    - Divisione Anatomia Patologica Presidio San Giovanni di Dio
  - Cagliari, Italy, 09124
    - Oculistica AOU di Cagliari Presidio San Giovanni di Dio
  - Firenze, Italy, 50134
    - Dipartimento Neuromuscoloscheletrico e Organi di Senso, "Oncologia Oculare Unit"
  - Firenze, Italy, 50134
    - SC oncologia Medica I - Azienda Ospedaliero Universitaria Careggi
  - Milano, Italy, 20162
    - Grande Ospedale Metropolitano Niguarda
  - Milano, Italy, 20141
    - Radiologia
  - Milano, Italy, 20141
    - Unita di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini
  - Modena, Italy, 41124
    - Dipartimento Interaziendale Farmaceutico - AOU Policlinico di Modena
  - Modena, Italy, 41124
    - SC di Oftalmologia - AOU Policlinico di Modena
  - Modena, Italy, 41124
    - SC di Radiologia, Dipartimento Interaziendale integrato Diagnostica per Immagini
  - Modena, Italy, 41124
    - SSD Day Hospital Oncologico - Dipartimento ad attivita integrata di Oncologia, Ematologia
  - Napoli, Italy, 80131
    - AOU Universita degli Studi della Campania L. Vanvitelli - DAI di Medicina Interna e Specialistica
  - Napoli, Italy, 80131
    - AOU Universita degli Studi della Campania L. Vanvitelli - U. Ma.Ca.
  - Napoli, Italy, 80131
    - AOU Università degli Studi della Campania L. Vanvitelli
  - Napoli, Italy, 80138
    - AOU Università degli Studi della Campania L. Vanvitelli
  - Pisa, Italy, 56124
    - UO Oculistica - AOU Pisana, Stabilimento Ospedaliero di Cisanello
  - Pisa, Italy, 56126
    - SOD Radiodiagnostica 3 - AOU Pisana, Stabilimento Ospedaliero di Santa Chiara
  - Pisa, Italy, 56126
    - UO Farmaceutica, Gestione del Farmaco - AOU Pisana, Stabilimento Ospedaliero di Santa Chiara
  - Pisa, Italy, 56126
    - UO Oncologia Medica 2 - AOU Pisana, Stabilimento Ospedaliero di Santa Chiara
  - Roma, Italy, 00133
    - U.O.S.D. Oncologia Medica, Dipartimento di Medicina - Fondazione PTV Policlinico Tor Vergata
  - Roma, Italy, 00133
    - U.O.S.D. Patologie Retiniche - Fondazione PTV Policlinico Tor Vergata
- Ancona
  - Torrette Di Ancona, Ancona, Italy, 60020
    - Ospedali Riuniti Umberto I
- BG
  - Bergamo, BG, Italy, 24127
    - Oculistica, ASST Papa Giovanni XXIII
  - Bergamo, BG, Italy, 24127
    - Oncologia, ASST Papa Giovanni XXIII
- Bergamo
  - Treviglio, Bergamo, Italy, 24047
    - ASST Bergamo Ovest, Ospedale Treviglio Caravaggio di Trevigl
- CR
  - Cremona, CR, Italy, 26100
    - Oculistica - ASST Cremona, Ospedale di Cremona
  - Cremona, CR, Italy, 26100
    - SC Farmacia Aziendale - ASST Cremona, Ospedale di Cremona
  - Cremona, CR, Italy, 26100
    - SC Oncologia - ASST Cremona, Ospedale di Cremona
- Cagliari
  - Monserrato, Cagliari, Italy, 09042
    - Clinica di Oncologia Medica AOU di Cagliari Presidio Duilio Casula Monserrato
  - Monserrato, Cagliari, Italy, 09042
    - Farmacia AOU di Cagliari Presidio Duilio Casula Monserrato
  - Monserrato, Cagliari, Italy, 09042
    - Radiologia AOU di Cagliari Presidio Duilio Casula Monserrato
- MI
  - Milano, MI, Italy, 20132
    - IRCCS Ospedale San Raffaele - U.O. di Medicina Oncologica
  - Milano, MI, Italy, 20132
    - Servizio di Farmacia - IRCCS Ospedale San Raffaele
  - Milano, MI, Italy, 20133
    - S.C. Radiologia diagnostica e interventistica - Fondazione IRCCS Istituto Nazionale dei Tumori
  - Milano, MI, Italy, 20133
    - SC Oncologia Medica 1, SS Oncologia Medica Gastroenterologica
- Milan
  - Rozzano (MI), Milan, Italy, 20089
    - U.O. di Oncologia ed Ematologia, Istituto Clinico HUMANITAS
- Milano
  - Rozzano, Milano, Italy, 20089
    - U.O. Oculistica, Istituto Clinico HUMANITAS
- PD
  - Padova, PD, Italy, 35128
    - Cardiologia per i pazienti oncologici - Istituto Oncologico Veneto I.R.C.C.S
  - Padova, PD, Italy, 35128
    - Clinica Oculistica - Azienda Ospedaliera di Padova
  - Padova, PD, Italy, 35128
    - U.O. Oncologia Medica 1 - Istituto Oncologico Veneto I.R.C.C.S
Japan
- - Fukuoka, Japan, 811-1395
    - National Hospital Organization Kyushu Cancer Center
  - Fukuoka, Japan, 815-8588
    - Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers
  - Osaka, Japan, 540-0006
    - National Hospital Organization Osaka National Hospital
- Aichi
  - Nagoya, Aichi, Japan, 464-8681
    - Aichi Cancer Center Hospital
  - Nagoya, Aichi, Japan, 464-0092
    - Chayagasaka Eye Clinic
- Chiba
  - Kashiwa-shi, Chiba, Japan, 277-8577
    - National Cancer Center Hospital East
- Hokkaido
  - Sapporo, Hokkaido, Japan, 060-8648
    - Hokkaido University Hospital
- Ishikawa
  - Kanazawa, Ishikawa, Japan, 920-8641
    - Kanazawa University Hospital
- Kanagawa
  - Kawasaki, Kanagawa, Japan, 216-8511
    - St. Marianna University School of Medicine Hospital
  - Yokohama, Kanagawa, Japan, 241-8515
    - Kanagawa Cancer Center
  - Yokohama, Kanagawa, Japan, 241-0821
    - Tsukahara Eye Clinic
- Osaka
  - Suita, Osaka, Japan, 565-0871
    - Osaka University Hospital Laboratory for Clinical Investigation
- Tokyo
  - Chuo-ku, Tokyo, Japan, 104-0045
    - National Cancer Center Hospital
Korea, Republic of
- - Busan, Korea, Republic of, 49201
    - Dong-A University Hospital
  - Incheon, Korea, Republic of, 21565
    - Gachon University Gil Medical Center
  - Seoul, Korea, Republic of, 03080
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 03722
    - Severance Hospital, Yonsei University Health System
  - Seoul, Korea, Republic of, 05505
    - Asan Medical Center
  - Seoul, Korea, Republic of, 06591
    - The Catholic University of Korea, Seoul St. Mary's Hospital
  - Seoul, Korea, Republic of, 06351
    - Samsung Medical Center
  - Seoul, Korea, Republic of, 02841
    - Korea University Anam Hospital IRB
- Gyeonggi-do
  - Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
    - Seoul National University Bundang Hospital
  - Suwon, Gyeonggi-do, Korea, Republic of, 16499
    - Ajou University Hospital
- Gyeonggido
  - Anyang, Gyeonggido, Korea, Republic of, 14068
    - Hallym University Sacred Heart Hospital
- Jeollanam-do
  - Hwasun-gun, Jeollanam-do, Korea, Republic of, 58128
    - Chonnam National University Hwasun Hospital
- Seoul Teugbyeolsi
  - Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308
    - Korea University Guro Hospital
Mexico
- Ciudad DE Mexico
  - Delegacion Cuauhtemoc, Ciudad DE Mexico, Mexico, 06760
    - Superare Centro de Infusion S.A. de C.V.
- Cuauhtemoc
  - Ciudad de Mexico, Cuauhtemoc, Mexico, 06760
    - Consultorio dentro de la Torre Medica Dalinde (Oncologia Medica)
Netherlands
- - Utrecht, Netherlands, 3584 CX
    - Universitair Medisch Centrum Utrecht
  - Utrecht, Netherlands, 3584CX
    - Universitair Medisch Centrum Utrecht
- Gelderland
  - Arnhem, Gelderland, Netherlands, 6815 AD
    - Rijnstate Hospital Arnhem
  - Velp, Gelderland, Netherlands, 6883 AZ
    - Rijnstate Hospital Velp
- Limburg
  - Maastricht, Limburg, Netherlands, 6229HX
    - Maastricht University Medical Center (MUMC)
- Noord-holland
  - Amsterdam, Noord-holland, Netherlands, 1066 CX
    - The Netherlands Cancer Institute
  - Amsterdam, Noord-holland, Netherlands, 1091 AC
    - Onze Lieve Vrouwen Gasthuis
- Zuid-holland
  - Den Haag, Zuid-holland, Netherlands, 2545 AA
    - Haga ziekenhuis
Norway
- - Lommedalen, Norway, 1350
    - Colosseum Øyelegesenter C/O LB Holdings AS
  - Oslo, Norway, 0369
    - Colosseum Øyelegesenter C/O LB Holdings AS
  - Oslo, Norway, 0379
    - Oslo universitetssykehus, Radiumhospitalet
  - Oslo, Norway, 0379
    - Sykehusapoteket Oslo, Radiumhospitalet
Poland
- - Brzozow, Poland, 36-200
    - Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
  - Elblag, Poland, 82-300
    - Wojewodzki Szpital Zespolony, Oddzial Onkologiczny
  - Krakow, Poland, 31-826
    - Szpital Specjalistyczny im. L. Rydygiera w Krakowie Sp.z.o.o.
  - Otwock, Poland, 05-400
    - Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
  - Poznan, Poland, 61-485
    - NZOZ Centrum Medyczne HCP
  - Poznan, Poland, 61495
    - NZOZ Przychodnia Specjalistyczna GUTMED
  - Warszawa, Poland, 01-748
    - MAGODENT Sp. z o.o. Szpital Elblaska
Russian Federation
- - Chelyabinsk, Russian Federation, 454048
    - Evimed LLC
  - Moscow, Russian Federation, 115478
    - Federal State Budget Institution "N.N. Blokhin Russian Cancer Research Center" of the
  - Moscow, Russian Federation, 115478
    - Federal State Budget Institution "N.N. Blokhin Russian Cancer Research Center"
  - Obninsk, Russian Federation, 249036
    - A. Tsyb Medical Radiological Research Center - branch of the
  - Sankt-Petersburg, Russian Federation, 197022
    - State Budgetary Educational Institution of Higher Professional Education First Saint Petersburg
- Kursk Region
  - Kursk, Kursk Region, Russian Federation, 305524
    - Regional Budgetary Healthcare Institution Kursk Regional Clinical
Spain
- - Barcelona, Spain, 08003
    - Hospital Del Mar
  - Barcelona, Spain, 08035
    - Hospital Universitario Vall d'Hebron
  - Barcelona, Spain, 08017
    - Clinica Corachan
  - Barcelona, Spain, 08023
    - Hospital Quiron Salud Barcelona
  - Barcelona, Spain, 08029
    - Cetir Centre Medic S.L.
  - Burgos, Spain, 09006
    - Hospital Universitario de Burgos
  - Cordoba, Spain, 14008
    - Consulta Dr. Juan Carlos Castillo Dominguez
  - Madrid, Spain, 28034
    - Hospital Universitario Ramon Y Cajal
  - Madrid, Spain, 28040
    - Hospital Clinico San Carlos
  - Madrid, Spain, 28040
    - Hospital Universitario Fundacion Jimenez Diaz
  - Madrid, Spain, 28041
    - Hospital Universitario 12 de Octubre
  - Madrid, Spain, 28046
    - Hospital Universitario La Paz
  - Madrid, Spain, 28007
    - Hospital General Universitario Gregorio Maranon
  - Madrid, Spain, 28006
    - Gabinete Radiologico Dr. Pita
  - Madrid, Spain, 28050
    - Hospital HM Universitario Sanchinarro
  - Sevilla, Spain, 41013
    - Hospital Universitario Virgen Del Rocio
  - Valencia, Spain, 46009
    - Fundación Instituto Valenciano de Oncología
  - Valencia, Spain, 46010
    - Hospital Clínico Universitario de Valencia
  - Valencia, Spain, 46014
    - Hospital General Universitario de Valencia
  - Valencia, Spain, 46004
    - Clinica Oftalvist
  - Zaragoza, Spain, 50009
    - Hospital Universitario Miguel Servet
  - Zaragoza, Spain, 50006
    - Hospital Quiron Salud Zaragoza
- Andalucia
  - Jaen, Andalucia, Spain, 23007
    - Complejo Hospitalario de Jaén
  - Jaen, Andalucia, Spain, 23007
    - Sercosa - Clinica de las Nieves
- Baleares
  - Palma de Mallorca, Baleares, Spain, 07010
    - Hospital Universitario Son Espases
- Barcelona
  - L'Hospitalet de Llobregat, Barcelona, Spain, 08908
    - Institut Catala d'Oncologia
  - Sabadell, Barcelona, Spain, 08208
    - Hospital Universitari Parc Tauli
- Cordona
  - Cordoba, Cordona, Spain, 14004
    - Hospital Universitario Reina Sofia
- Madrid, Communidad Delaware
  - Madrid, Madrid, Communidad Delaware, Spain, 28006
    - Hospital Nuestra Señora del Rosario
- Tarragona
  - Reus, Tarragona, Spain, 43204
    - Hospital Universitari Sant Joan de Reus
Taiwan
- - Kaohsiung, Taiwan, 807
    - Kaohsiung Medical University Chung-Ho Memorial Hospital
  - Taichung, Taiwan, 40447
    - China Medical University Hospital
  - Tainan, Taiwan, 704
    - National Cheng Kung University Hospital
  - Taipei, Taiwan, 10002
    - National Taiwan University Hospital
  - Taoyuan city, Taiwan, 333
    - Chang Gung Memorial Hospital, Linkou
- Changhua County
  - Changhua city, Changhua County, Taiwan, 500
    - Changhua Christian Hospital
Turkey
- - Ankara, Turkey, 06230
    - Hacettepe University Medical Faculty
  - Bursa, Turkey, 16059
    - Uludag University Hospital
  - Edirne, Turkey, 22030
    - Trakya Universitesi Tip Fakultesi
  - Malatya, Turkey, 44280
    - Inonu Universitesi Turgut Ozal Medical Center
- Bornova
  - Izmir, Bornova, Turkey, 35040
    - Ege University Medical Faculty
- Izmir, Karsiyaka
  - Izmir, Izmir, Karsiyaka, Turkey, 35575
    - Izmir Medical Park Hospital - Medical Oncology
- Kadikoy
  - Istanbul, Kadikoy, Turkey, 34722
    - Medeniyet University Goztepe Training and Research Hospital
Ukraine
- Dnipropetrovska Oblast'
  - Dnipropetrovsk, Dnipropetrovska Oblast', Ukraine, 41100
    - Oftalmolohycheskyi tsentr "Vzghliad" MTs
  - Dnipropetrovsk, Dnipropetrovska Oblast', Ukraine, 49027
    - Oftalmolohycheskyi tsentr "Vzghliad" MTs
  - Dnipropetrovsk, Dnipropetrovska Oblast', Ukraine, 49102
    - Derzhavnyi zaklad, Dnipropetrovska medychna akademiia Ministerstva okhorony zdorovia Ukrainy
  - Dnipropetrovsk, Dnipropetrovska Oblast', Ukraine, 49102
    - Komumalnyi zaklad, Dnipropetrovska miska bahatoprofilna klinichna likarnia Nº4
- Kyivska Oblast
  - Kyiv, Kyivska Oblast, Ukraine, 01601
    - Natsionalnyi medychnyi universytet imeni O.O Bohomltsia, kafedra oftalmolohii
  - Kyiv, Kyivska Oblast, Ukraine, 01601
    - Oleksandrivska klinichna likarnia mista Kyieva
  - Kyiv, Kyivska Oblast, Ukraine, 03115
    - Kyivskyi miskyi klinichnyi onkotsentr
- Kyivska Oblast'
  - Kyiv, Kyivska Oblast', Ukraine, 02096
    - Kyivska klinichna likarnia na zaliznychnomu transporti No3 filii Tsentr okhorony zdorov'ia PAT
  - Kyiv, Kyivska Oblast', Ukraine, 02096
    - Natsionalnyi medychnyi universytet imeni O.O Bohomltsia, kafedra onkolohii
- Vinnyts'ka Oblast'
  - Vinnytsia, Vinnyts'ka Oblast', Ukraine, 21029
    - Vinnytskyi oblasnyi klinichnyi onkolohichnyi dyspanser, viddilennia khimioterapii
- Zakarpats'ka Oblast'
  - Uzhgorod, Zakarpats'ka Oblast', Ukraine, 88000
    - DVNZ "Uzhhorodskyi natsionalnyi universytet"
  - Uzhgorod, Zakarpats'ka Oblast', Ukraine, 88000
    - Tsentralna miska klinichna likarnia, Miskyi onkolohichnyi tsentr
- Zakarpatska Oblast
  - Uzhhorod, Zakarpatska Oblast, Ukraine, 88000
    - DVNZ "Uzhhorodskyi natsionalnyi universytet"
  - Uzhhorod, Zakarpatska Oblast, Ukraine, 88000
    - TOV "Zakarpatskyi Tsentr Mikrokhirurhii Oka"
United Kingdom
- - London, United Kingdom, W12 0HS
    - Imperial College Healthcare NHS Trust, Hammersmith Hospital
  - London, United Kingdom, W1G 6AD
    - Sarah Cannon Research Institute UK
  - London, United Kingdom, W12 0HS
    - Hammersmith Hospital, Imperial College Healthcare NHS Trust
  - London, United Kingdom, W6 8RF
    - Imperial College Healthcare NHS Trust, Charing Cross Hospital
  - Manchester, United Kingdom, M20 4BX
    - The Christie NHS Foundation Trust - Christie Hospital
- Aberdeenshire Scotland
  - Aberdeen, Aberdeenshire Scotland, United Kingdom, AB25 2ZN
    - NHS Grampian - Aberdeen Royal Infirmary
- Berkshire
  - Windsor, Berkshire, United Kingdom, SL4 3DP
    - King Edward V11 Hospital
- Glasglow City, Scotland
  - Glasglow, Glasglow City, Scotland, United Kingdom, G12 0YH
    - Beatson West of Scotland Cancer Centre
- WEST Midlands
  - Birmingham, WEST Midlands, United Kingdom, B15 2TH
    - University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital
United States
- Arizona
  - Phoenix, Arizona, United States, 85054
    - Mayo Clinic Hospital
  - Phoenix, Arizona, United States, 85054
    - Mayo Clinic
  - Scottsdale, Arizona, United States, 85259
    - Mayo Clinic
- California
  - Duarte, California, United States, 91010
    - City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
  - Fountain Valley, California, United States, 92708
    - Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.
  - Los Angeles, California, United States, 90033
    - USC/Norris Comprehensive Cancer Center
  - Los Angeles, California, United States, 90033
    - Keck Hospital of USC
  - Los Angeles, California, United States, 90033
    - LAC+USC Medical Center
  - Los Angeles, California, United States, 90033
    - Keck Hospital of USC - Norris Healthcare Center (HC3)
  - Los Angeles, California, United States, 90033
    - Norris Healthcare Center 3 (HC3)
  - Los Angeles, California, United States, 90033
    - USC Eye Institute
  - Newport Beach, California, United States, 92663
    - Hoag Memorial Hospital Presbyterian
  - Orange, California, United States, 92868
    - Harvard Eye Associates
- Colorado
  - Aurora, Colorado, United States, 80045
    - University of Colorado Cancer Center - Anschutz Cancer Pavilion
  - Aurora, Colorado, United States, 80045
    - Rocky Mountain Lions Eye Institute
  - Aurora, Colorado, United States, 80045
    - University of Colorado Denver CTO (CTRC)
  - Aurora, Colorado, United States, 80045
    - University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
  - Aurora, Colorado, United States, 80045
    - University of Colorado Hospital Inpatient Pavillion'
- Connecticut
  - New Haven, Connecticut, United States, 06520
    - Yale University, Yale Cancer Center
  - New Haven, Connecticut, United States, 06510
    - Smilow Cancer Hospital at Yale - New Haven
  - New Haven, Connecticut, United States, 06510
    - Temple Medical Center
  - North Haven, Connecticut, United States, 06473
    - Smilow Cancer Hospital Care Center at North Haven
- Florida
  - Coral Gables, Florida, United States, 33146
    - The Lennar Foundation Medical Center
  - Fort Lauderdale, Florida, United States, 33316
    - Broward Health Medical Center
  - Fort Lauderdale, Florida, United States, 33316
    - Dr. Clayton Berger (opthalmology)
  - Fort Lauderdale, Florida, United States, 33316
    - Mehmet F. Hepgur, MD - Broward Health Medical Center
  - Jacksonville, Florida, United States, 32224
    - Mayo Clinic Florida
  - Miami, Florida, United States, 33136
    - Sylvester Comprehensive Cancer Center/UMHC
  - Miami, Florida, United States, 33176
    - Sylvester at Kendall
- Illinois
  - Bloomington, Illinois, United States, 61704
    - Illinois CancerCare- Bloomington
  - Chicago, Illinois, United States, 60637
    - University of Chicago Medical Center
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare- Galesburg
  - New Lenox, Illinois, United States, 60451
    - University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
  - Orland Park, Illinois, United States, 60462
    - The University of Chicago Medicine Center for Advanced Care Orland Park
  - Ottawa, Illinois, United States, 61350
    - Illinois CancerCare- Ottawa
  - Peoria, Illinois, United States, 61615
    - Illinois Eye Center
  - Peoria, Illinois, United States, 61615
    - Illinois Cancer Care, PC
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Indiana University Health Melvin and Bren Simon Cancer Center
  - Indianapolis, Indiana, United States, 46202
    - Indiana University Health Hospital
  - Indianapolis, Indiana, United States, 46202
    - Investigational Drug Services IUHSCC
  - Indianapolis, Indiana, United States, 46202
    - Sidney &Lois Eskenazi Hospital
  - Indianapolis, Indiana, United States, 46290
    - IU Health Springmill
  - New Albany, Indiana, United States, 47150
    - Baptist Health Floyd Cancer Center
- Iowa
  - Iowa City, Iowa, United States, 52242
    - University of Iowa Hospitals and Clinics
- Kansas
  - Fairway, Kansas, United States, 66205
    - The University of Kansas Clinical Research Center
  - Kansas City, Kansas, United States, 66160
    - The University of Kansas Hospital
  - Prairie Village, Kansas, United States, 66208
    - KU Eye
  - Westwood, Kansas, United States, 66205
    - The University of Kansas Cancer Center and Medical Pavilion
  - Westwood, Kansas, United States, 66205
    - The University of Kansas Cancer Center, Investigational Drug Services
- Louisiana
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Clinic Foundation
- Maryland
  - Baltimore, Maryland, United States, 21287
    - The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  - Baltimore, Maryland, United States, 21287
    - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  - Baltimore, Maryland, United States, 21287
    - The Investigational Drug Pharmacy (IDS) in the Sidney Kimmel Cancer Center at Johns Hopkins
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital
  - Boston, Massachusetts, United States, 02115
    - Brigham & Women'S Hospital
  - Boston, Massachusetts, United States, 02114
    - Ophthalmic Consultants of Boston Inc
  - Boston, Massachusetts, United States, 02215
    - Dana-Farber Cancer Institute (DFCI)
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic
- Missouri
  - Creve Coeur, Missouri, United States, 63141
    - Siteman Cancer Center - West County
  - Saint Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - Saint Louis, Missouri, United States, 63129
    - Siteman Cancer Center - South County
  - Saint Louis, Missouri, United States, 63110
    - Barnes Jewish Hospital
  - Saint Louis, Missouri, United States, 63110
    - Saint Louis University
  - Saint Louis, Missouri, United States, 63104
    - SSM Health Saint Louis University Hospital
  - Saint Louis, Missouri, United States, 63110
    - Washington University Infusion Center Pharmacy
  - Saint Louis, Missouri, United States, 63110
    - SSM Health Saint Louis University Hospital
  - Saint Peters, Missouri, United States, 63376
    - Siteman Cancer Center - St Peters
- New Jersey
  - Basking Ridge, New Jersey, United States, 07920
    - Memorial Sloan Kettering: Basking Ridge
- New York
  - Commack, New York, United States, 11725
    - Memorial Sloan Kettering: Commack
  - New York, New York, United States, 10065
    - Memorial Sloan Kettering Cancer Center
  - New York, New York, United States, 10065
    - Memorial Sloan Kettering: Rockefeller Outpatient Pavilion
- Ohio
  - Canton, Ohio, United States, 44718
    - Gabrail Cancer Center Research
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Taussig Cancer Institute
- Oregon
  - Portland, Oregon, United States, 97239
    - Oregon Health and Science University
  - Portland, Oregon, United States, 97239
    - OHSU Center for Health and Healing
  - Portland, Oregon, United States, 97239
    - OHSU Research Pharmacy Services
  - Portland, Oregon, United States, 97239
    - Casey Eye Institute-South Waterfront
- Tennessee
  - Nashville, Tennessee, United States, 37232
    - Henry-Joyce Cancer Clinic
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt Eye Institute
- Texas
  - Houston, Texas, United States, 77030-4009
    - The University of Texas MD Anderson Cancer Center
  - Temple, Texas, United States, 76504
    - Scott & White Clinic - Temple Pavilion
  - Temple, Texas, United States, 76508
    - Scott & White Medical Center - Temple
- Washington
  - Spokane, Washington, United States, 99204
    - Spokane Eye Clinic
  - Spokane, Washington, United States, 99208
    - Inland Imaging, LLC Holy Family Hospital
  - Spokane, Washington, United States, 99208
    - Medical Oncology Associates, PS DBA Summit Cancer Centers
  - Spokane, Washington, United States, 99208
    - Providence Holy Family Nuclear Medicine
  - Spokane Valley, Washington, United States, 99216
    - Medical Oncology Associates, PS DBA Summit Cancer Centers
- Wisconsin
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Clinical Science Center

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

Key Inclusion Criteria:

Age ≥ 18 years at time of informed consent
Histologically- or cytologically-confirmed CRC that is metastatic
Presence of BRAFV600E in tumor tissue as previously determined by a local assay at any time prior to Screening or by the central laboratory
Progression of disease after 1 or 2 prior regimens in the metastatic setting
Evidence of measurable or evaluable non-measurable disease per RECIST, v1.1
Adequate bone marrow, cardiac, kidney and liver function
Able to take oral medications
Female patients are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks, or must agree to take appropriate precautions to avoid pregnancy from screening through follow-up if of childbearing potential
Males must agree to take appropriate precautions to avoid fathering a child from screening through follow-up

Key Exclusion Criteria:

Prior treatment with any RAF inhibitor, MEK inhibitor, cetuximab, panitumumab or other epidermal growth factor receptor (EGFR) inhibitors
Prior irinotecan hypersensitivity or toxicity that would suggest an inability to tolerate irinotecan 180 mg/m2 every 2 weeks
Symptomatic brain metastasis or leptomeningeal disease
History or current evidence of retinal vein occlusion or current risk factors for retinal vein occlusion (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes)
Known history of acute or chronic pancreatitis
History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization
Uncontrolled blood pressure despite medical treatment
Impaired GI function or disease that may significantly alter the absorption of encorafenib or binimetinib (e.g., ulcerative diseases, uncontrolled vomiting, malabsorption syndrome, small bowel resection with decreased intestinal absorption)
Concurrent or previous other malignancy within 5 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other noninvasive or indolent malignancy
History of thromboembolic or cerebrovascular events ≤ 6 months prior to starting study treatment, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis or pulmonary emboli
Concurrent neuromuscular disorder that is associated with the potential of elevated creatine (phosphor)kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
Residual common terminology criteria for adverse events (CTCAE) ≥ Grade 2 toxicity from any prior anticancer therapy, with the exception of Grade 2 alopecia or Grade 2 neuropathy
Known history of HIV infection
Active hepatitis B or hepatitis C infection
Known history of Gilbert's syndrome
Known contraindication to receive cetuximab or irinotecan at the planned doses

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: Sequential Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Safety Lead-in, Triplet Arm Encorafenib + binimetinib + cetuximab.	Drug: Encorafenib Orally, once daily. Drug: Binimetinib Orally, twice daily. Drug: Cetuximab Standard of care.
Experimental: Doublet Arm Encorafenib + cetuximab.	Drug: Encorafenib Orally, once daily. Drug: Cetuximab Standard of care.
Active Comparator: Control Arm Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab.	Drug: Cetuximab Standard of care. Drug: Irinotecan Standard of care. Drug: Folinic Acid Standard of care. Other Names: FA Drug: 5-Fluorouracil Standard of care. Other Names: 5-FU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Safety Lead-in) Number of Participants With Dose-Limiting Toxicities (DLTs) Time Frame: Cycle 1 (up to 28 days)		Cycle 1 (up to 28 days)
(Safety Lead-in) Number of Participants With Adverse Events (AEs) Time Frame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle)	An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Number of participants reporting AEs were reported in this outcome measure.	Duration of safety lead-in, approximately 6 months (up to 28 days per cycle)
(Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Interim Analysis Time Frame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle)	An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Number of participants with dose interruptions, dose modifications and dose discontinuations due to AEs were reported in this outcome measure.	Duration of safety lead-in, approximately 6 months (up to 28 days per cycle)
(Safety Lead-in) Incidence of Dose Interruptions, Dose Modifications and Discontinuations Due to Adverse Events (AEs) - Final Analysis Time Frame: From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks)	An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Number of participants according to incidence of dose interruptions, dose modifications and dose discontinuations due to AEs were reported in this outcome measure.	From start of study treatment until 30 days post last dose of study treatment (maximum treatment exposure of 280 weeks)
(Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Interim Analysis Time Frame: From randomization to death due to any cause until 204 deaths were observed (maximum treatment exposure of 89.1 weeks for triplet arm and 52.4 weeks for control arm)	OS was defined as the time from randomization to death due to any cause.	From randomization to death due to any cause until 204 deaths were observed (maximum treatment exposure of 89.1 weeks for triplet arm and 52.4 weeks for control arm)
(Phase 3) Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 of Triplet Arm vs. Control Arm Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle)	ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of complete response (CR) or partial response (PR), where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 millimeter [mm] short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits.	Duration of Phase 3, approximately 6 months (up to 28 days per cycle)

Secondary Outcome Measures

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm - Final Analysis Time Frame: From randomization to death due to any cause (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)	OS was defined as the time from randomization to death due to any cause.	From randomization to death due to any cause (maximum treatment exposure of 277.4 weeks for triplet arm and 108 weeks for control arm)

Collaborators and Investigators

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

Sponsor

Pfizer

Collaborators

Merck KGaA, Darmstadt, Germany

Ono Pharmaceutical Co. Ltd

Pierre Fabre Medicament

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

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 13, 2016

Primary Completion (Actual)

February 11, 2019

Study Completion (Actual)

November 10, 2022

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

October 6, 2016

First Posted (Estimated)

October 10, 2016

Study Record Updates

Last Update Posted (Actual)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

ARRAY-818-302
BEACON CRC (Other Identifier: Alias Study Number)
2015-005805-35 (EudraCT Number)
C4221009 (Other Identifier: Pfizer)

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

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.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

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

Other 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 (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimated)

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

Clinical Trials on BRAF V600E-mutant Metastatic Colorectal Cancer

Clinical Trials on Encorafenib

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