NCT05203172|RecruitingPhase 4FDA Drug

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

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

Pfizer ClinicalTrials.gov

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4 other identifiers

C4221026FLOTILLA2023-509408-13-002023

Study Type

interventional

Target

210

Locations

20 countries

Sites

Timeline

RegisteredJan 2022

StartedJul 2022

CompletionJun 2032

Brief 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. 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

210

participants targeted

Target at P75+ for phase_4

Timeline

70mo left

Started Jul 2022

Longer than P75 for phase_4

Geographic Reach

20 countries

77 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10 years study duration

Study Progress43%

Jul 2022Jun 2032

First Submitted

Initial submission to the registry

January 10, 2022

Completed

14 days until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed

5 months until next milestone

Study Start

First participant enrolled

July 5, 2022

Completed

7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2029

Expected

2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2032

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

7.1 years

First QC Date

January 10, 2022

Last Update Submit

September 29, 2026

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

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

Study Arms (9)

Sub-Study C4221004C

EXPERIMENTAL

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.

Drug: BinimetinibDrug: EncorafenibDrug: Vemurafenib

Sub-Study C4221005C

EXPERIMENTAL

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.

Drug: BinimetinibDrug: EncorafenibDrug: Ribociclib

Sub-Study C4211001C / C4211003C

EXPERIMENTAL

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.

Drug: Binimetinib

Sub-Study C4221003C / C4221006C / C4221013C

EXPERIMENTAL

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.

Drug: BinimetinibDrug: Encorafenib

Sub-Study C4221009C / W00090 GE 2 01C

EXPERIMENTAL

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.

Drug: BinimetinibDrug: EncorafenibBiological: Cetuximab

Sub-Study C4221008C

EXPERIMENTAL

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.

Drug: BinimetinibDrug: Encorafenib

Sub-Study C4221016C / C4221023C

EXPERIMENTAL

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.

Drug: BinimetinibDrug: EncorafenibBiological: PembrolizumabBiological: Nivolumab

Sub-Study C4221010C

EXPERIMENTAL

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.

Drug: Encorafenib

Sub-Study C4221015C / C4221022C

EXPERIMENTAL

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.

Drug: EncorafenibBiological: CetuximabDrug: 5-FluorouracilDrug: LeucovorinDrug: OxaliplatinDrug: IrinotecanDrug: CapecitabineBiological: Bevacizumab

Interventions

BinimetinibDRUG

Binimetinib is administered orally twice a day.

Also known as: PF-06811462, MEK162, ARRY-438162, ONO-7703, Mektovi®, W0074

Sub-Study C4211001C / C4211003CSub-Study C4221003C / C4221006C / C4221013CSub-Study C4221004CSub-Study C4221005CSub-Study C4221008CSub-Study C4221009C / W00090 GE 2 01CSub-Study C4221016C / C4221023C

EncorafenibDRUG

Encorafenib is administered orally once a day.

Also known as: PF-07263896, LGX818, ONO-7702, Braftovi®, W0090

Sub-Study C4221003C / C4221006C / C4221013CSub-Study C4221004CSub-Study C4221005CSub-Study C4221008CSub-Study C4221009C / W00090 GE 2 01CSub-Study C4221010CSub-Study C4221015C / C4221022CSub-Study C4221016C / C4221023C

VemurafenibDRUG

Vemurafenib is administered orally twice a day.

Also known as: Zelboraf®

Sub-Study C4221004C

RibociclibDRUG

Ribociclib is administered orally once a day.

Also known as: LEE011, Kisqali®

Sub-Study C4221005C

CetuximabBIOLOGICAL

Cetuximab is administered intravenously (IV) every 2 weeks.

Also known as: Erbitux®

Sub-Study C4221009C / W00090 GE 2 01CSub-Study C4221015C / C4221022C

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.

Also known as: Keytruda®

Sub-Study C4221016C / C4221023C

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.

Also known as: Opdivo®

Sub-Study C4221016C / C4221023C

5-FluorouracilDRUG

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

Also known as: 5-FU