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A maximum of 35 administrations will be given, including doses already given in the Parent Study.",[55],[122],"Keytruda®",{"type":111,"name":124,"description":125,"armGroupLabels":126,"otherNames":127},"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.",[55],[128],"Opdivo®",{"type":76,"name":130,"description":131,"armGroupLabels":132,"otherNames":133},"5-Fluorouracil","5-FU is administered intravenously (IV) every 2 weeks.",[65],[134],"5-FU",{"type":76,"name":136,"description":137,"armGroupLabels":138,"otherNames":139},"Leucovorin","Leucovorin is administered intravenously (IV) every 2 weeks. 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Zaitsev NAMS of Ukraine","Kharkiv","Kharkiv Oblast","61018","Ukraine","UA",{"type":186,"coordinates":855},[856,857],36.25475,49.98177,{"lat":857,"lon":856},{"facility":860,"status":179,"city":861,"state":862,"zip":863,"country":864,"countryCode":865,"cosmosGeoPoint":866,"geoPoint":870,"contacts":11},"Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital","Preston","Lancashire","PR2 9HT","United Kingdom","UK",{"type":186,"coordinates":867},[868,869],-2.70452,53.76282,{"lat":869,"lon":868},{"type":872,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100454871","phase-4-the-flotilla-study-providing-continued-access-to-the-study-medicines-encorafenib-and-binimetinib-for-participants-in-prior-clinical-trials-100454871",false,"NCT05203172","The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials","ENCORAFENIB\u002FBINIMETINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM ENCORAFENIB\u002FBINIMETINIB CLINICAL STUDIES","Inclusion Criteria:\n\n* Any participant who is receiving study intervention and deriving clinical benefit (as determined by the principal investigator) in an encorafenib\u002Fbinimetinib Parent Study, with no ongoing NCI CTCAE version 4.03 Grade ≥3 or intolerable Grade 2 AEs considered to be related to study treatment.\n* Participants must agree to follow the reproductive criteria as outlined in the applicable Encorafenib\u002FBinimetinib Continuation Sub-Study Protocol.\n\nExclusion Criteria:\n\n\\- Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.","ALL","18 Years",{"count":883,"type":884},210,"ESTIMATED","INTERVENTIONAL",[887],"PHASE4","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\u002For binimetinib.\n\nAll participants who took part in earlier encorafenib and\u002For 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.\n\nParticipants 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.",[890],"Solid Tumors","2026-09-29",{"date":893,"type":894},"2026-10-02","ACTUAL",{"date":896,"type":894},"2022-07-05",{"date":898,"type":884},"2032-06-30",{"name":5,"class":6},77]