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Solid TumorsPhase 4NCT05203172

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

A Phase 4 study testing Binimetinib, Encorafenib and Vemurafenib in people with Solid Tumors, run by Pfizer at 77 sites in 20 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
Binimetinib, Encorafenib and Vemurafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
77 sitesin 20 countries
Study dates
5 Jul 2022to 30 Jun 2032
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.

Trial locations and contacts

77 sites in 20 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

77 sites in 20 countries

United States18 sites, 15 recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Recruiting

  • Emory University Hospital

    Atlanta, Georgia, 30322

    Recruiting

  • Investigational Drug Service Emory University Clinic

    Atlanta, Georgia, 30322

    Recruiting

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

    Recruiting

  • MSK Basking Ridge

    Basking Ridge, New Jersey, 07920

    Active, not recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Recruiting

  • Duke Cancer Center

    Durham, North Carolina, 27710

    Recruiting

  • Investigational Chemotherapy Service

    Durham, North Carolina, 27710

    Recruiting

  • Rockefeller Outpatient Pavilion (53rd Street)

    New York, New York, 10022

    Active, not recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Active, not recruiting

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85004

    Recruiting

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

    Recruiting

  • HealthPartners Cancer Research Center

    Saint Paul, Minnesota, 55101

    Recruiting

  • Regions Hospital Pharmacy

    Saint Paul, Minnesota, 55101

    Recruiting

  • Siteman Cancer Center

    St Louis, Missouri, 63108

    Recruiting

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Recruiting

  • Washington University

    St Louis, Missouri, 63110

    Recruiting

Other trials in United States

Spain13 sites, 10 recruiting

  • CHUAC-Hospital Teresa Herrera

    A Coruña, A Coruña [LA Coruña], 15006

    Active, not recruiting

  • Institut Català d'Oncologia (ICO) - Badalona

    Badalona, Barcelona [barcelona], 08916

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [barcelona], 08035

    Recruiting

  • Hospital Clinic de Barcelona

    Barcelona, Catalunya [cataluña], 08008

    Recruiting

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [cataluña], 08036

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

    Recruiting

  • Hospital Universitario Arnau de Vilanova de Lleida

    Lleida, Lleida [lérida], 25198

    Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

    Recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, Comunidad de, 28222

    Active, not recruiting

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

    Recruiting

  • H.R.U Málaga - Hospital General

    Málaga, 29011

    Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

    Active, not recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

    Recruiting

Other trials in Spain

Italy8 sites, 7 recruiting

  • Instituto Tumori Giovanni Paolo II

    Bari, Apulia, 70124

    Recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

    Bologna, 40138

    Recruiting

  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

    Candiolo, Torino, 10060

    Recruiting

  • Istituto Europeo di Oncologia IRCCS

    Milan, 20141

    Active, not recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Naples, 80131

    Recruiting

  • Istituto Oncologico Veneto IRCCS

    Padova, Veneto, 35128

    Recruiting

  • Azienda Ospedaliera Di Perugia

    Perugia, PG, 06132

    Recruiting

  • Istituto Nazionale Tumori Regina Elena

    Rome, ROMA, 00144

    Recruiting

Other trials in Italy

Brazil6 sites, 6 recruiting

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, São Paulo, 14.780-070

    Recruiting

  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia

    Ijuí, Rio Grande do Sul, 98700-000

    Recruiting

  • Liga Norte Riograndense Contra o Câncer

    Natal, Rio Grande do Norte, 59062-000

    Recruiting

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

    Not yet recruiting

  • BP - A Beneficencia Portuguesa de São Paulo

    São Paulo, São Paulo, 01321-001

    Recruiting

  • Real e Benemerita Associacao Portuguesa de Beneficencia

    São Paulo, São Paulo, 01323-030

    Recruiting

Other trials in Brazil

Canada3 sites, 3 recruiting

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Recruiting

  • University Health Network

    Toronto, Ontario, M5G 2C4

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    Recruiting

Other trials in Canada

Czechia3 sites, 3 recruiting

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

    Recruiting

  • Lekarna Fakultni nemocnice Olomouc

    Olomouc, 779 00

    Recruiting

  • Vseobecna fakultni nemocnice v Praze

    Prague, Praha 2, 12808

    Recruiting

Other trials in Czechia

Germany3 sites, 1 recruiting

  • Charité Universitaetsmedizin Berlin - Campus Mitte

    Berlin, 10117

    Recruiting

  • Otto-von-Guericke-Universitat Magdeburg

    Magdeburg, Saxony-Anhalt, 39120

    Active, not recruiting

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

    Active, not recruiting

Other trials in Germany

Netherlands3 sites, 2 recruiting

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)

    Amsterdam, North Holland, 1066 CX

    Recruiting

  • Radboudumc

    Nijmegen, Gelderland, 6525 GA

    Recruiting

  • Isala, locatie Zwolle

    Zwolle, 8025 AB

    Active, not recruiting

Other trials in Netherlands

Russia3 sites, 3 recruiting

  • Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF

    Moscow, 115478

    Recruiting

  • N.N.Petrov Research Institute of Oncology

    Saint Petersburg, Sankt-Peterburg, 197758

    Recruiting

  • N.N.Petrov Research Institute of Oncology

    Saint Petersburg, 197758

    Recruiting

Other trials in Russia

South Korea3 sites, 3 recruiting

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 03080

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [seoul], 03722

    Recruiting

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 06351

    Recruiting

Other trials in South Korea

France2 sites

  • Hopital Claude Huriez - CHU de Lille

    Lille, NORD, 59037

    Active, not recruiting

  • Gustave Roussy

    Villejuif, Val-de-marne, 94800

    Active, not recruiting

Other trials in France

Greece2 sites, 2 recruiting

  • General Hospital of Athens ''Laiko''

    Athens, Attikí, 115 27

    Recruiting

  • General Hospital of Athens "Laiko"

    Athens, Attikí, 11527

    Recruiting

Other trials in Greece

Hungary2 sites, 2 recruiting

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

    Recruiting

  • Pécsi Tudományegyetem Klinikai Központ

    Pécs, Baranya, 7632

    Recruiting

Other trials in Hungary

Portugal2 sites, 1 recruiting

  • Instituto Português de Oncologia de Lisboa Francisco Gentil

    Lisbon, Lisbon District, 1099-023

    Recruiting

  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072

    Active, not recruiting

Other trials in Portugal

Australia1 site, 1 recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

    Recruiting

Other trials in Australia

Israel1 site, 1 recruiting

  • Rambam Health Care Campus

    Haifa, Northern District, 3109601

    Recruiting

Other trials in Israel

Slovakia1 site

  • Narodny onkologicky ustav

    Bratislava, Bratislava Region, 833 10

    Active, not recruiting

Other trials in Slovakia

Turkey (Türkiye)1 site, 1 recruiting

  • Memorial Ankara Hastanesi

    Ankara, Turkiye, 06520

    Recruiting

Other trials in Turkey (Türkiye)

Ukraine1 site, 1 recruiting

  • Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine

    Kharkiv, Kharkiv Oblast, 61018

    Recruiting

Other trials in Ukraine

United Kingdom1 site, 1 recruiting

  • Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital

    Preston, Lancashire, PR2 9HT

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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 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.

Read the 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 individual encorafenib/binimetinib continuation sub-study protocols that cover each eligible Parent Study. Up to approximately 210 participants from 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; C4221004 - NCT01909453; C4221005 - NCT01543698; C4221006 - NCT03911869; C4221008 - NCT03915951; C4221009 - NCT02928224; C4221010 - NCT01436656; C4221013 - NCT02159066; ANCHOR-CRC - NCT03693170; C4221015 - NCT04607421; C4221016 - NCT04657991; C4221022 - NCT05217446; C4221023 - NCT05926960

Conditions
Solid Tumors
Being tested
Binimetinib, Encorafenib, Vemurafenib, Ribociclib, Cetuximab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BinimetinibDrug

    Also called PF-06811462, MEK162, ARRY-438162, ONO-7703

    Binimetinib is administered orally twice a day.

  • EncorafenibDrug

    Also called PF-07263896, LGX818, ONO-7702, Braftovi®

    Encorafenib is administered orally once a day.

  • VemurafenibDrug

    Also called Zelboraf®

    Vemurafenib is administered orally twice a day.

  • RibociclibDrug

    Also called LEE011, Kisqali®

    Ribociclib is administered orally once a day.

  • CetuximabBiological

    Also called Erbitux®

    Cetuximab is administered intravenously (IV) every 2 weeks.

  • PembrolizumabBiological

    Also called Keytruda®

    Pembrolizumab is administered intravenously (IV) every 3 weeks. A maximum of 35 administrations will be given, including doses already given in the Parent Study.

  • NivolumabBiological

    Also called Opdivo®

    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-FluorouracilDrug

    Also called 5-FU

    5-FU is administered intravenously (IV) every 2 weeks.

  • LeucovorinDrug

    Also called Calcium folinate, Folinic acid

    Leucovorin is administered intravenously (IV) every 2 weeks. Levo-leucovorin may be given as an alternative for leucovorin.

  • OxaliplatinDrug

    Also called Eloxatin®

    Oxaliplatin is administered intravenously (IV) every 2 or 3 weeks.

  • IrinotecanDrug

    Also called Campostar®

    Irinotecan is administered intravenously (IV) every 2 weeks.

  • CapecitabineDrug

    Also called Xeloda®

    Capecitabine is administered orally twice a day for 14 consecutive days, followed by 7 days off.

  • BevacizumabBiological

    Also called Avastin®, Zirabev

    Bevacizumab will be administered intravenously (IV), if applicable.

Study groups in NCT05203172
Study groupRoleWhat they receive
Sub-Study C4221004CExperimentalContinued treatment access for participants from the C4221004 (ARRAY CMEK162B2301, COLUMBUS) Encorafenib and Binimetinib study. Each participant will receive the same study treatment as received in the Parent Study.
Receives: Drug: Binimetinib; Drug: Encorafenib; Drug: Vemurafenib
Sub-Study C4221005CExperimentalContinued treatment access for participants from the C4221005 (ARRAY CMEK162X2110) Encorafenib and Binimetinib study. Each participant will receive the same study treatment as received in the Parent Study.
Receives: Drug: Binimetinib; Drug: Encorafenib; Drug: Ribociclib
Sub-Study C4211001C / C4211003CExperimentalContinued treatment access for participants from the C4211001 (ARRAY CMEK162×2201) and the C4211003 (ARRAY-162-311, MILO) Binimetinib studies. Each participant will receive the same study treatment as received in the Parent Study.
Receives: Drug: Binimetinib
Sub-Study C4221003C / C4221006C / C4221013CExperimentalContinued treatment access for participants from the C4221003 (ARRAY-818-103), C4221006 (ARRAY-818-201) and the C4221013 (ARRAY CLGX818X2109) Encorafenib and Binimetinib studies. Each participant will receive the same study treatment as received in the Parent Study.
Receives: Drug: Binimetinib; Drug: Encorafenib
Sub-Study C4221009C / W00090 GE 2 01CExperimentalContinued treatment access for participants from the C4221009 (ARRAY-818-302, BEACON) and W00090 GE 2 01 (ANCHOR CRC) Encorafenib, Binimetinib and Cetuximab studies. Each participant will receive the same study treatment as received in the Parent Study.
Receives: Drug: Binimetinib; Drug: Encorafenib; Biological: Cetuximab
Sub-Study C4221008CExperimentalContinued treatment access for participants from the C4221008 (ARRAY-818-202, PHAROS) Encorafenib and Binimetinib study. Each participant will receive the same study treatment as received in the Parent Study.
Receives: Drug: Binimetinib; Drug: Encorafenib
Sub-Study C4221016C / C4221023CExperimentalContinued treatment access for participants from the C4221016 (STARBOARD) and C4221023 (PORTSIDE) Encorafenib and Binimetinib studies. Each participant will receive the same study treatment as received in the Parent Study.
Receives: Drug: Binimetinib; Drug: Encorafenib; Biological: Pembrolizumab; Biological: Nivolumab
Sub-Study C4221010CExperimentalContinued treatment access for participant from the C4221010 (CLGX818X2101) Encorafenib study. Each participant will receive the same study treatment as received in the Parent Study.
Receives: Drug: Encorafenib
Sub-Study C4221015C / C4221022CExperimentalContinued treatment access for participants from the C4221015 (BREAKWATER) and C4221022 (SEAMARK) Encorafenib studies. Each participant will receive the same study treatment as received in the Parent Study.
Receives: Drug: Encorafenib; Biological: Cetuximab; Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Irinotecan; Drug: Capecitabine; Biological: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with adverse events leading to permanent discontinuation of study intervention

    Measured: Baseline up to approximately 5 years

  2. Number serious adverse events reported for all participants

    Measured: Baseline up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2022
  2. Study start5 Jul 2022
  3. Primary completion31 Jul 2029 (estimated)
  4. Study completion30 Jun 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Each participant will continue to receive the same study treatment regimen at the same dose level as that received in the Parent Study. The details of study intervention and duration of treatment are specified in the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol.
Masking
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05203172
Sponsor's protocol ID
C4221026
Other IDs
FLOTILLA, 2023-509408-13-00, 2023
Status last verified
Oct 2026
First submitted
10 Jan 2022
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Binimetinib, Encorafenib and Vemurafenib in people with Solid Tumors, run by Pfizer at 77 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States, Spain, Italy, Brazil, Canada and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse events leading to permanent discontinuation of study intervention (time frame: Baseline up to approximately 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05203172.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.

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