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

ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPfizer

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Binimetinib

    Drug

    Binimetinib is administered orally twice a day.

  • Encorafenib

    Drug

    Encorafenib is administered orally once a day.

  • Vemurafenib

    Drug

    Vemurafenib is administered orally twice a day.

  • Ribociclib

    Drug

    Ribociclib is administered orally once a day.

  • Cetuximab

    Biological/Vaccine

    Cetuximab is administered intravenously (IV) every 2 weeks.

  • Pembrolizumab

    Biological/Vaccine

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

  • Nivolumab

    Biological/Vaccine

    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.

  • 5-Fluorouracil

    Drug

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

  • Leucovorin

    Drug

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

  • Oxaliplatin

    Drug

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

  • Irinotecan

    Drug

    Irinotecan is administered intravenously (IV) every 2 weeks.

  • Capecitabine

    Drug

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

  • Bevacizumab

    Biological/Vaccine

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

Treatment groups

210 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Sub-Study C4221004CExperimental treatment 3 interventions
Group B: Sub-Study C4221005CExperimental treatment 3 interventions
Group C: Sub-Study C4211001C / C4211003CExperimental treatment 1 intervention
Group D: Sub-Study C4221003C / C4221006C / C4221013CExperimental treatment 2 interventions
Group E: Sub-Study C4221009C / W00090 GE 2 01CExperimental treatment 3 interventions
Group F: Sub-Study C4221008CExperimental treatment 2 interventions
Group G: Sub-Study C4221016C / C4221023CExperimental treatment 4 interventions
Group H: Sub-Study C4221010CExperimental treatment 1 intervention
Group I: Sub-Study C4221015C / C4221022CExperimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline up to approximately 5 years
2

Number serious adverse events reported for all participants

Time frame
Baseline up to approximately 5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pfizer

Lead sponsor

Source ClinicalTrials.gov
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