Master Protocol for Encorafenib/Binimetinib Continuation Sub-Studies (FLOTILLA Study)
Research type
Research Study
Full title
ENCORAFENIB/BINIMETINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM ENCORAFENIB/BINIMETINIB CLINICAL STUDIES
IRAS ID
1007157
Contact name
Adam Schayowitz
Contact email
Sponsor organisation
Pfizer Inc
Eudract number
2021-004395-34
Research summary
This study is being submitted with the scope to enroll participants currently on treatment with encorafenib, binimetinib in the Parent Study C4221004 (ARRAY CMEK162B2301, COLUMBUS, EudraCT 2013-001176-38).
The master protocol is designed in response to investigator interest to ensure continued access to study treatment free-of-charge to patients who have actively participated in encorafenib/binimetinib clinical trials, which have completed analyses and are ready to close or were prematurely terminated.
Study C4221026 is open only for the limited number of patients who, as confirmed by their oncologist/investigator, continue to derive significant benefit from the study treatment with encorafenib/binimetinib (single agents, in combination and/or in combination with other treatments). Patients enrolled in Study C4221026 have been receiving treatment for a long period of time, namely patients ongoing in Parent Study C4221004 have been receiving treatment for more than 7 years.
This study offers the same treatment regimen that the patients are currently receiving in the parent study. If a patient has discontinued one of the treatments given in combination in the parent study due to toxicity but continues to derive benefit from the other treatment, that continuing treatment is also available as monotherapy.REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0669
Date of REC Opinion
4 Sep 2023
REC opinion
Further Information Favourable Opinion