Pfizer
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.
This is an open-label, continuation study for participants receiving study intervention(s) in an encorafenib/binimetinib Parent Study. The study is being conducted under a Master Protocol for Encorafenib/Binimetinib Continuation Sub-Studies, with individual encorafenib/binimetinib continuation sub-study protocols that cover each eligible Parent Study. Up to approximately 210 participants from qualifying Parent Studies will be included in this Encorafenib/Binimetinib Continuation study. This continuation study includes multiple sub-study protocols to allow participants from each of the followi…
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 inclusio…
Binimetinib is administered orally twice a day.
Encorafenib is administered orally once a day.
Vemurafenib is administered orally twice a day.
Ribociclib is administered orally once a day.
Cetuximab is administered intravenously (IV) every 2 weeks.
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 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-FU is administered intravenously (IV) every 2 weeks.
Leucovorin is administered intravenously (IV) every 2 weeks. Levo-leucovorin may be given as an alternative for leucovorin.
Oxaliplatin is administered intravenously (IV) every 2 or 3 weeks.
Irinotecan is administered intravenously (IV) every 2 weeks.
Capecitabine is administered orally twice a day for 14 consecutive days, followed by 7 days off.
Bevacizumab will be administered intravenously (IV), if applicable.