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The FLOTILLA Study: Continued Access to Encorafenib and Binimetinib for Solid Tumors

The FLOTILLA study offers continued access to specific cancer medicines, encorafenib and binimetinib, for people who previously participated in earlier clinical trials involving these drugs. This study is for individuals with solid tumors who are still benefiting from these treatments, as determined by their doctor. The study will also continue to monitor the safety of these medicines. You cannot join this study if you haven't been in a previous encorafenib or binimetinib trial, or if you stopped receiving treatment in a prior study. The goal is to track side effects, including serious ones, for up to five years.

Study design
This is an open-label study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll about 46 participants who were in earlier encorafenib/binimetinib studies.
What's involved
You will continue to receive encorafenib and/or binimetinib, possibly with cetuximab or ribociclib, at doses similar to your previous study. The study will monitor for side effects for up to approximately five years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events and serious adverse events for up to approximately five years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05203172

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
Pfizer
~46 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:Binimetinib only treatmentEncorafenib only TreatmentEncorafenib & Binimetinib TreatmentTreatment of Encorafenib & Binimetinib & RibociclibTreatment of Encorafenib & Binimetinib & Cetuximab

At a glance

Recruiting sites
57 of 67 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events leading to permanent discontinuation of study intervention
Measured over Baseline up to approximately 5 years
+1 more outcome measured

Conditions

Solid Tumors

Explore related trials

Solid Neoplasm

NCT05203172

Where you'd take part

This study runs at 67 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Barnes-Jewish Hospital

    St Louis, Missourino site contact published

    Recruiting

  • BP - A Beneficencia Portuguesa de São Paulo

    São Paulo, São Paulo, Brazilno site contact published

    Recruiting

  • Charité Universitaetsmedizin Berlin - Campus Mitte

    Berlin, Germanyno site contact published

    Recruiting

  • CHUAC-Hospital Teresa Herrera

    A Coruña, A Coruña [LA Coruña], Spainno site contact published

    Recruiting

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, Hungaryno site contact published

    Recruiting

  • Duke Cancer Center

    Durham, North Carolinano site contact published

    Recruiting

  • Emory University Hospital

    Atlanta, Georgiano site contact published

    Recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of participants with adverse events leading to permanent discontinuation of study interventionBaseline up to approximately 5 years
  • Number serious adverse events reported for all participantsBaseline up to approximately 5 years