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

RecruitingPhase 4

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

Who can join

Ages 18 and older · All sexes

Full 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.

About the 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 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.

What is being tested

Binimetinib only treatment (drug)
Encorafenib only Treatment (drug)
Encorafenib & Binimetinib Treatment (drug)
Treatment of Encorafenib & Binimetinib & Ribociclib (drug)
Treatment of Encorafenib & Binimetinib & Cetuximab (drug)

Sponsor: Pfizer · Participants: 46 · Started: Jul 5, 2022

Contact the study team

Pfizer CT.gov Call Center · Phone: 1-800-718-1021

Official record on ClinicalTrials.gov — NCT05203172

Locations in the U.S.

Arizona	St. Joseph's Hospital and Medical Center, Phoenix St. Joseph's Hospital and Medical Center, Phoenix
Georgia	Emory University Hospital, Atlanta Emory University Hospital Midtown, Atlanta Investigational Drug Service Emory University Clinic, Atlanta Winship Cancer Institute of Emory University, Atlanta
Massachusetts	Massachusetts General Hospital, Boston
Minnesota	HealthPartners Cancer Research Center, Saint Paul Regions Hospital Pharmacy, Saint Paul
Missouri	Barnes-Jewish Hospital, St Louis Siteman Cancer Center, St Louis Washington University, St Louis Washington University School of Medicine, St Louis
North Carolina	Duke Cancer Center, Durham Investigational Chemotherapy Service, Durham

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.