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

Condition(s) studied

Investigational drug(s) / intervention(s)

Binimetinib: Binimetinib is administered orally twice a day.

Encorafenib: Encorafenib is administered orally once a day.

Vemurafenib: Vemurafenib is administered orally twice a day.

Ribociclib: Ribociclib is administered orally once a day.

Cetuximab: Cetuximab is administered intravenously (IV) every 2 weeks.

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.

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.

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

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

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

Irinotecan: Irinotecan is administered intravenously (IV) every 2 weeks.

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

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

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (77)

+ 37 more sites — see the full list on the official registry below.

On this site

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