NCT05203172 · Pfizer
The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials
What this study is about
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.
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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.
Interventions
DRUG
Binimetinib
Binimetinib is administered orally twice a day.
DRUG
Encorafenib
Encorafenib is administered orally once a day.
DRUG
Vemurafenib
Vemurafenib is administered orally twice a day.
DRUG
Ribociclib
Ribociclib is administered orally once a day.
BIOLOGICAL
Cetuximab
Cetuximab is administered intravenously (IV) every 2 weeks.
BIOLOGICAL
Pembrolizumab
Pembrolizumab is administered intravenously (IV) every 3 weeks. A maximum of 35 administrations will be given, including doses already given in the Parent Study.
BIOLOGICAL
Nivolumab
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.
DRUG
5-Fluorouracil
5-FU is administered intravenously (IV) every 2 weeks.
DRUG
Leucovorin
Leucovorin is administered intravenously (IV) every 2 weeks. Levo-leucovorin may be given as an alternative for leucovorin.
DRUG
Oxaliplatin
Oxaliplatin is administered intravenously (IV) every 2 or 3 weeks.
DRUG
Irinotecan
Irinotecan is administered intravenously (IV) every 2 weeks.
DRUG
Capecitabine
Capecitabine is administered orally twice a day for 14 consecutive days, followed by 7 days off.
BIOLOGICAL
Bevacizumab
Bevacizumab will be administered intravenously (IV), if applicable.
Primary outcome measures
Number of participants with adverse events leading to permanent discontinuation of study intervention
Time frame: Baseline up to approximately 5 years
Number serious adverse events reported for all participants
Time frame: Baseline up to approximately 5 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Phoenix, Arizona
- Atlanta, Georgia
- Boston, Massachusetts
- Saint Paul, Minnesota
- St Louis, Missouri
- Basking Ridge, New Jersey
- New York, New York
- Durham, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 19, 2026 · Source of record for eligibility and locations