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RECRUITING Phase 4 ClinicalTrials.gov

The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT05203172

Registry updated: 2026-10-19
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Description

The purpose of this clinical trial (called the FLOTILLA study) is to give continued access to the study medicines, as well as safety follow-up, for participants in prior clinical trials of encorafenib and/or binimetinib. All participants who took part in earlier encorafenib and/or binimetinib studies may participate in the FLOTILLA study if they are still benefiting from the use of the study medicines. This will be determined by the study doctor. People may not participate in the FLOTILLA study if they were not enrolled in a prior study of encorafenib or binimetinib. Participants who had enrolled but had stopped receiving the study treatment in a prior study cannot be enrolled in this study. Participants in the FLOTILLA study will receive study treatment at the same dose and frequency as in their prior study, for up to about 5 years.

Interventions

  • Binimetinib (Drug)
    Binimetinib is administered orally twice a day.
  • Encorafenib (Drug)
    Encorafenib is administered orally once a day.
  • Vemurafenib (Drug)
    Vemurafenib is administered orally twice a day.
  • Ribociclib (Drug)
    Ribociclib is administered orally once a day.
  • Cetuximab (Biological)
    Cetuximab is administered intravenously (IV) every 2 weeks.
  • Pembrolizumab (Biological)
    Pembrolizumab is administered intravenously (IV) every 3 weeks. A maximum of 35 administrations will be given, including doses already given in the Parent Study.
  • Nivolumab (Biological)
    Nivolumab is administered intravenously (IV) every 4 week. A maximum of 24 months of treatment will be given, beginning with the first dose in the Parent Study.
  • 5-Fluorouracil (Drug)
    5-FU is administered intravenously (IV) every 2 weeks.
  • Leucovorin (Drug)
    Leucovorin is administered intravenously (IV) every 2 weeks. Levo-leucovorin may be given as an alternative for leucovorin.
  • Oxaliplatin (Drug)
    Oxaliplatin is administered intravenously (IV) every 2 or 3 weeks.
  • Irinotecan (Drug)
    Irinotecan is administered intravenously (IV) every 2 weeks.
  • Capecitabine (Drug)
    Capecitabine is administered orally twice a day for 14 consecutive days, followed by 7 days off.
  • Bevacizumab (Biological)
    Bevacizumab will be administered intravenously (IV), if applicable.

Eligibility criteria

Inclusion Criteria: * Any participant who is receiving study intervention and deriving clinical benefit (as determined by the principal investigator) in an encorafenib/binimetinib Parent Study, with no ongoing NCI CTCAE version 4.03 Grade ≥3 or intolerable Grade 2 AEs considered to be related to study treatment. * Participants must agree to follow the reproductive criteria as outlined in the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol. Exclusion Criteria: \- Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.

Conditions

Solid Tumors

Locations

  • St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
  • St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
  • Emory University Hospital Midtown — Atlanta, Georgia, United States
  • Emory University Hospital — Atlanta, Georgia, United States
  • Investigational Drug Service Emory University Clinic — Atlanta, Georgia, United States
  • Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
  • Massachusetts General Hospital — Boston, Massachusetts, United States
  • HealthPartners Cancer Research Center — Saint Paul, Minnesota, United States
  • Regions Hospital Pharmacy — Saint Paul, Minnesota, United States
  • Siteman Cancer Center — St Louis, Missouri, United States
  • Barnes-Jewish Hospital — St Louis, Missouri, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Washington University — St Louis, Missouri, United States
  • MSK Basking Ridge — Basking Ridge, New Jersey, United States
  • Rockefeller Outpatient Pavilion (53rd Street) — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • Duke Cancer Center — Durham, North Carolina, United States
  • Investigational Chemotherapy Service — Durham, North Carolina, United States
  • Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
  • Liga Norte Riograndense Contra o Câncer — Natal, Rio Grande do Norte, Brazil
  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia — Ijuí, Rio Grande do Sul, Brazil
  • Hospital de Clinicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil
  • Fundação Pio XII - Hospital de Câncer de Barretos — Barretos, São Paulo, Brazil
  • BP - A Beneficencia Portuguesa de São Paulo — São Paulo, São Paulo, Brazil
  • Real e Benemerita Associacao Portuguesa de Beneficencia — São Paulo, São Paulo, Brazil
  • University Health Network — Toronto, Ontario, Canada
  • Princess Margaret Cancer Centre — Toronto, Ontario, Canada
  • Jewish General Hospital — Montreal, Quebec, Canada
  • Vseobecna fakultni nemocnice v Praze — Prague, Praha 2, Czechia
  • Fakultni nemocnice Olomouc — Olomouc, Czechia
  • Lekarna Fakultni nemocnice Olomouc — Olomouc, Czechia
  • Hopital Claude Huriez - CHU de Lille — Lille, NORD, France
  • Gustave Roussy — Villejuif, Val-de-marne, France
  • Universitaetsklinikum Tuebingen — Tübingen, Baden-Wurttemberg, Germany
  • Otto-von-Guericke-Universitat Magdeburg — Magdeburg, Saxony-Anhalt, Germany
  • Charité Universitaetsmedizin Berlin - Campus Mitte — Berlin, Germany
  • General Hospital of Athens ''Laiko'' — Athens, Attikí, Greece
  • General Hospital of Athens "Laiko" — Athens, Attikí, Greece
  • Pécsi Tudományegyetem Klinikai Központ — Pécs, Baranya, Hungary
  • Debreceni Egyetem Klinikai Kozpont — Debrecen, Hungary
  • Rambam Health Care Campus — Haifa, Northern District, Israel
  • Instituto Tumori Giovanni Paolo II — Bari, Apulia, Italy
  • Azienda Ospedaliera Di Perugia — Perugia, PG, Italy
  • Istituto Nazionale Tumori Regina Elena — Rome, ROMA, Italy
  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia — Candiolo, Torino, Italy
  • Istituto Oncologico Veneto IRCCS — Padova, Veneto, Italy
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola — Bologna, Italy
  • Istituto Europeo di Oncologia IRCCS — Milan, Italy
  • Istituto Nazionale Tumori IRCCS Fondazione Pascale — Naples, Italy
  • Radboudumc — Nijmegen, Gelderland, Netherlands
  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) — Amsterdam, North Holland, Netherlands
  • Isala, locatie Zwolle — Zwolle, Netherlands
  • Instituto Português de Oncologia de Lisboa Francisco Gentil — Lisbon, Lisbon District, Portugal
  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE — Porto, Portugal
  • N.N.Petrov Research Institute of Oncology — Saint Petersburg, Sankt-Peterburg, Russia
  • Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF — Moscow, Russia
  • N.N.Petrov Research Institute of Oncology — Saint Petersburg, Russia
  • Narodny onkologicky ustav — Bratislava, Bratislava Region, Slovakia
  • Seoul National University Hospital — Seoul, Seoul-teukbyeolsi [seoul], South Korea
  • Severance Hospital, Yonsei University Health System — Seoul, Seoul-teukbyeolsi [seoul], South Korea
  • Samsung Medical Center — Seoul, Seoul-teukbyeolsi [seoul], South Korea
  • CHUAC-Hospital Teresa Herrera — A Coruña, A Coruña [LA Coruña], Spain
  • Institut Català d'Oncologia (ICO) - Badalona — Badalona, Barcelona [barcelona], Spain
  • Hospital Universitari Vall d'Hebron — Barcelona, Barcelona [barcelona], Spain
  • Hospital Universitario Marqués de Valdecilla — Santander, Cantabria, Spain
  • Hospital Clinic de Barcelona — Barcelona, Catalunya [cataluña], Spain
  • Hospital Clínic de Barcelona — Barcelona, Catalunya [cataluña], Spain
  • Hospital Universitario Arnau de Vilanova de Lleida — Lleida, Lleida [lérida], Spain
  • Hospital Universitario Puerta de Hierro Majadahonda — Majadahonda, Madrid, Comunidad de, Spain
  • Hospital Universitari Vall d'Hebron — Barcelona, Spain
  • Hospital Universitario HM Sanchinarro — Madrid, Spain
  • Hospital Regional Universitario de Malaga — Málaga, Spain
  • H.R.U Málaga - Hospital General — Málaga, Spain
  • Hospital Universitario Central de Asturias — Oviedo, Spain
  • Memorial Ankara Hastanesi — Ankara, Turkiye, Turkey (Türkiye)
  • Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine — Kharkiv, Kharkiv Oblast, Ukraine
  • Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital — Preston, Lancashire, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record