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CLINICAL STUDY · NCT05203172

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

RecruitingPhase 4Interventional

Sponsored by Pfizer

Condition
Solid Tumors
Study locations
77 reported sites
Study updated
19 Oct 2026
Source
ClinicalTrials.gov

Overall study status is shown above. Individual hospitals may have a different recruitment status.

THE STUDY

About this study

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

PARTICIPATION

Who may participate

Minimum age
18 Years
Maximum age
Not reported
Sex eligibility
All sexes
Healthy volunteers
Not accepted

Only the study team can confirm eligibility. The registry criteria below are not a medical recommendation.

Full inclusion and exclusion 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.

NEAR YOU

Study locations worldwide

77 sites

Check the individual site’s status and contact the listed study team for current availability.

WHAT IS BEING STUDIED

Treatments and study groups

Interventions

BinimetinibDrug
Binimetinib is administered orally twice a day.

Study groups: Sub-Study C4211001C / C4211003C, Sub-Study C4221003C / C4221006C / C4221013C, Sub-Study C4221004C, Sub-Study C4221005C, Sub-Study C4221008C, Sub-Study C4221009C / W00090 GE 2 01C, Sub-Study C4221016C / C4221023C

Other names: PF-06811462, MEK162, ARRY-438162, ONO-7703, Mektovi®, W0074

EncorafenibDrug
Encorafenib is administered orally once a day.

Study groups: Sub-Study C4221003C / C4221006C / C4221013C, Sub-Study C4221004C, Sub-Study C4221005C, Sub-Study C4221008C, Sub-Study C4221009C / W00090 GE 2 01C, Sub-Study C4221010C, Sub-Study C4221015C / C4221022C, Sub-Study C4221016C / C4221023C

Other names: PF-07263896, LGX818, ONO-7702, Braftovi®, W0090

VemurafenibDrug
Vemurafenib is administered orally twice a day.

Study groups: Sub-Study C4221004C

Other names: Zelboraf®

RibociclibDrug
Ribociclib is administered orally once a day.

Study groups: Sub-Study C4221005C

Other names: LEE011, Kisqali®

CetuximabBiological
Cetuximab is administered intravenously (IV) every 2 weeks.

Study groups: Sub-Study C4221009C / W00090 GE 2 01C, Sub-Study C4221015C / C4221022C

Other names: Erbitux®

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

Study groups: Sub-Study C4221016C / C4221023C

Other names: Keytruda®

NivolumabBiological
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.

Study groups: Sub-Study C4221016C / C4221023C

Other names: Opdivo®

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

Study groups: Sub-Study C4221015C / C4221022C

Other names: 5-FU

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

Study groups: Sub-Study C4221015C / C4221022C

Other names: Calcium folinate, Folinic acid

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

Study groups: Sub-Study C4221015C / C4221022C

Other names: Eloxatin®

IrinotecanDrug
Irinotecan is administered intravenously (IV) every 2 weeks.

Study groups: Sub-Study C4221015C / C4221022C

Other names: Campostar®

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

Study groups: Sub-Study C4221015C / C4221022C

Other names: Xeloda®

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

Study groups: Sub-Study C4221015C / C4221022C

Other names: Avastin®, Zirabev

Study groups

Sub-Study C4221004CExperimental
Continued 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.

Interventions: Drug: Binimetinib, Drug: Encorafenib, Drug: Vemurafenib

Sub-Study C4221005CExperimental
Continued 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.

Interventions: Drug: Binimetinib, Drug: Encorafenib, Drug: Ribociclib

Sub-Study C4211001C / C4211003CExperimental
Continued 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.

Interventions: Drug: Binimetinib

Sub-Study C4221003C / C4221006C / C4221013CExperimental
Continued 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.

Interventions: Drug: Binimetinib, Drug: Encorafenib

Sub-Study C4221009C / W00090 GE 2 01CExperimental
Continued 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.

Interventions: Drug: Binimetinib, Drug: Encorafenib, Biological: Cetuximab

Sub-Study C4221008CExperimental
Continued 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.

Interventions: Drug: Binimetinib, Drug: Encorafenib

Sub-Study C4221016C / C4221023CExperimental
Continued 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.

Interventions: Drug: Binimetinib, Drug: Encorafenib, Biological: Pembrolizumab, Biological: Nivolumab

Sub-Study C4221010CExperimental
Continued treatment access for participant from the C4221010 (CLGX818X2101) Encorafenib study.

Each participant will receive the same study treatment as received in the Parent Study.

Interventions: Drug: Encorafenib

Sub-Study C4221015C / C4221022CExperimental
Continued 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.

Interventions: Drug: Encorafenib, Biological: Cetuximab, Drug: 5-Fluorouracil, Drug: Leucovorin, Drug: Oxaliplatin, Drug: Irinotecan, Drug: Capecitabine, Biological: Bevacizumab

RESEARCH DETAILS

Study design

Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non randomized
Study model
Parallel
Masking
None (open label)
Enrolment
210 participants · Estimated

Study model details

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.

TIMELINE & MEASURES

Dates and outcomes

Study started
5 Jul 2022 · Actual
Primary completion
31 Jul 2029 · Estimated
Study completion
30 Jun 2032 · Estimated
First registered
24 Jan 2022 · Actual
Last registry update
19 Oct 2026 · Actual
Status last verified
Oct 2026
Primary outcomes (2)

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

Not reported.

Time frame: Baseline up to approximately 5 years

Number serious adverse events reported for all participants

Not reported.

Time frame: Baseline up to approximately 5 years

STUDY TEAM

Sponsor and contacts

Lead sponsor
Pfizer
Sponsor type
Industry
Collaborators
Not reported
Organisation study ID
C4221026

Central study contacts

Pfizer CT.gov Call CenterContactPhone: 1-800-718-1021Email: ClinicalTrials.gov_Inquiries@pfizer.com
Study officials
Pfizer CT.gov Call CenterStudy director · Pfizer

Contacts are provided by the registry for study enquiries. Do not use these details for marketing or promotions.

FURTHER READING

Results, documents and references

No results are posted in this registry record

This does not mean the study has no findings. Results may not yet have been submitted or published here.

No study documents are listed in this record.

Related information

Source: ClinicalTrials.gov · Data fetched 20 Oct 2026, 16:40 GMT+0530

Registry data timestamp: 2026-10-19T09:00:04

Registry content is reformatted for readability; original study text is not rewritten. Missing information is labelled “Not reported”. Records are supplied by study sponsors or investigators and can change.

ClinicalTrials.gov does not endorse PharmaBharat. Listing a study does not mean it has been evaluated or approved by a government agency. Information is for research awareness and is not medical advice. Data source terms · Registry disclaimer

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