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

April 6, 2026 updated by: Pfizer

ENCORAFENIB/BINIMETINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM ENCORAFENIB/BINIMETINIB CLINICAL STUDIES

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 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 have not enrolled in a prior study of encorafenib or binimetinib.

Participants that had enrolled but had stopped receiving the study treatment in a prior study cannot enrolled in this study. Participants in the FLOTILLA study will receive encorafenib and/or binimetinib at the same dose and frequency as in their prior study, for up to about 5 years.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, continuation study for participants receiving study intervention(s) in an encorafenib/binimetinib Parent Study. The study is being conducted under a Master Protocol for Encorafenib/Binimetinib Continuation Sub-Studies with an individual encorafenib/binimetinib continuation sub-study protocol for each eligible Parent Study. Approximately 75 participants from potentially qualifying Parent Studies will be included in this Encorafenib/Binimetinib Continuation study.

This continuation study includes multiple sub-study protocols to allow participants from each of the following parent studies: C4211001 - NCT01320085; C4211003 - NCT01849874; C4221003 - NCT03864042; C4221005 - NCT01543698; C4221006 - NCT03911869; C4221009 - NCT02928224; C4221010 - NCT01436656; C4221013 - NCT02159066; ANCHOR-CRC - NCT03693170

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 4

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

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Centre
  • Brazil
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59062-000
        • Recruiting
        • Liga Norte Riograndense Contra O Cancer
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brazil, 98700-000
        • Recruiting
        • ONCOSITE - Centro de Pesquisa Clinica em Oncologia
    • São Paulo
      • Barretos, São Paulo, Brazil, 14.780-070
        • Recruiting
        • Fundacao Pio Xii - Hospital De Cancer De Barretos
      • São Paulo, São Paulo, Brazil, 01321-001
        • Recruiting
        • BP - A Beneficencia Portuguesa de São Paulo
      • São Paulo, São Paulo, Brazil, 01323-030
        • Recruiting
        • Real e Benemerita Associacao Portuguesa de Beneficencia
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • University Health Network
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Jewish General Hospital
  • Czechia
    • Praha 2
      • Prague, Praha 2, Czechia, 12808
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze
  • France
    • NORD
      • Lille, NORD, France, 59037
        • Active, not recruiting
        • Hopital Claude Huriez - CHU de Lille
    • Val-de-marne
      • Villejuif, Val-de-marne, France, 94800
        • Active, not recruiting
        • Gustave Roussy
  • Germany
      • Berlin, Germany, 10117
        • Recruiting
        • Charité Universitaetsmedizin Berlin - Campus Mitte
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Active, not recruiting
        • Universitaetsklinikum Tuebingen
    • Saxony-Anhalt
      • Magdeburg, Saxony-Anhalt, Germany, 39120
        • Active, not recruiting
        • Otto-von-Guericke-Universität Magdeburg
  • Hungary
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont
  • Israel
    • Northern District
      • Haifa, Northern District, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
      • Milan, Italy, 20141
        • Active, not recruiting
        • Istituto Europeo di Oncologia IRCCS
      • Naples, Italy, 80131
        • Recruiting
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale
    • Apulia
      • Bari, Apulia, Italy, 70124
        • Recruiting
        • Instituto Tumori Giovanni Paolo II
    • ROMA
      • Rome, ROMA, Italy, 00144
        • Recruiting
        • Istituto Nazionale Tumori Regina Elena
    • Torino
      • Candiolo, Torino, Italy, 10060
        • Recruiting
        • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto IRCCS
  • Netherlands
      • Zwolle, Netherlands, 8025 AB
        • Active, not recruiting
        • Isala, locatie Zwolle
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Recruiting
        • Radboudumc
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1066 CX
        • Recruiting
        • Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)
  • Portugal
      • Porto, Portugal, 4200-072
        • Recruiting
        • Instituto Português de Oncologia do Porto Francisco Gentil, EPE
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1099-023
        • Recruiting
        • Instituto Português de Oncologia de Lisboa Francisco Gentil
  • Russia
      • Moscow, Russia, 115478
        • Recruiting
        • Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
      • Saint Petersburg, Russia, 197758
        • Recruiting
        • N.N.Petrov Research Institute of Oncology
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 197758
        • Recruiting
        • N.N.Petrov Research Institute of Oncology
  • Slovakia
    • Bratislava Region
      • Bratislava, Bratislava Region, Slovakia, 833 10
        • Active, not recruiting
        • Narodny onkologicky ustav
  • South Korea
    • Seoul-teukbyeolsi [seoul]
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario HM Sanchinarro
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Malaga
      • Málaga, Spain, 29011
        • Recruiting
        • H.R.U Málaga - Hospital General
      • Oviedo, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
    • A Coruña [LA Coruña]
      • A Coruña, A Coruña [LA Coruña], Spain, 15006
        • Recruiting
        • CHUAC-Hospital Teresa Herrera
    • Barcelona [barcelona]
      • Badalona, Barcelona [barcelona], Spain, 08916
        • Recruiting
        • Institut Català d'Oncologia (ICO) - Badalona
      • Barcelona, Barcelona [barcelona], Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
    • Catalunya [cataluña]
      • Barcelona, Catalunya [cataluña], Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
      • Barcelona, Catalunya [cataluña], Spain, 08008
        • Recruiting
        • Hospital Clinic de Barcelona
    • Lleida [lérida]
      • Lleida, Lleida [lérida], Spain, 25198
        • Recruiting
        • Hospital Universitario Arnau de Vilanova de Lleida
    • Madrid, Comunidad de
      • Majadahonda, Madrid, Comunidad de, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro Majadahonda
  • United Kingdom
    • Lancashire
      • Preston, Lancashire, United Kingdom, PR2 9HT
        • Recruiting
        • Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • St. Joseph's Hospital and Medical Center
      • Phoenix, Arizona, United States, 85004
        • Recruiting
        • St. Joseph's Hospital and Medical Center
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute of Emory University
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Investigational Drug Service Emory University Clinic
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital Pharmacy
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • HealthPartners Cancer Research Center
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
      • St Louis, Missouri, United States, 63108
        • Recruiting
        • Siteman Cancer Center
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Barnes-Jewish Hospital
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Active, not recruiting
        • MSK Basking Ridge
    • New York
      • New York, New York, United States, 10065
        • Active, not recruiting
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10022
        • Active, not recruiting
        • Rockefeller Outpatient Pavilion (53rd Street)
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Center
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Investigational Chemotherapy Service

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

No

Description

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.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Binimetinib only treatment
For those participants receiving binimetinib treatment in parent studies
Drug: Binimetinib only treatment
Binimetinib will be administered at the same dose level (15 mg to 45 mg) as that received in the Parent Studies C4211001 and C4211003 with water irrespective of food, continuously, starting on Day 1.
Experimental: Encorafenib only Treatment
For those participants receiving encorafenib only treatment in parent studies
Drug: Encorafenib only Treatment
Encorafenib will be self-administered at the same dose level as that received in the C4221010 Parent Study.
Experimental: Encorafenib & Binimetinib Treatment
For those participants receiving encorafenib & binimetinib treatment in parent studies.
Drug: Encorafenib & Binimetinib Treatment
Encorafenib will be administered on a 300 mg QD schedule and binimetinib will be administered on a 45 mg BID schedule, both orally as a flat fixed dose. Cetuximab will be administered at either 400 mg/m2 or 500 mg/m2 IV every 2 weeks on Days 1 and 15 of every cycle.
Experimental: Treatment of Encorafenib & Binimetinib & Ribociclib
For those participants receiving treatment of encorafenib & binimetinib & ribociclib in parent studies
Drug: Treatment of Encorafenib & Binimetinib & Ribociclib
Encorafenib capsule and ribociclib capsules or tablets will be co-administered orally QD with binimetinib tablets BID. The study drugs will be administered as a flat-fixed dose, and not by body weight or body surface area.
Experimental: Treatment of Encorafenib & Binimetinib & Cetuximab
For those participants receiving treatment of encorafenib & binimetinib & cetuximab in parent studies
Drug: Treatment of Encorafenib & Binimetinib & Cetuximab
Encorafenib will be administered on a 300 mg QD schedule and binimetinib will be administered on a 45 mg BID schedule, both orally as a flat fixed dose. Cetuximab will be administered at either 400 mg/m2 or 500 mg/m2 IV every 2 weeks on Days 1 and 15 of every cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events leading to permanent discontinuation of study intervention
Time Frame: Baseline up to approximately 5 years
Baseline up to approximately 5 years
Number serious adverse events reported for all participants
Time Frame: Baseline up to approximately 5 years
Baseline up to approximately 5 years

Collaborators and Investigators

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

Sponsor

Pfizer

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.

Helpful Links

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)

July 5, 2022

Primary Completion (Estimated)

July 31, 2029

Study Completion (Estimated)

July 31, 2029

Study Registration Dates

First Submitted

January 10, 2022

First Submitted That Met QC Criteria

January 10, 2022

First Posted (Actual)

January 24, 2022

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C4221026
  • FLOTILLA (Other Identifier: Alias Study Number)
  • 2023-509408-13-00 (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

No

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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