Encorafenib and biNimetinib Followed by CEmiplimab and FiAnLimab in Patients With BRAF Mutant melanOma and Symptomatic Brain Metastases

PHASE2RecruitingINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

May 29, 2025

Primary Completion Date

January 31, 2028

Study Completion Date

January 31, 2028

Conditions
Melanoma BRAF V600E/K MutatedMelanoma and Brain Metastases
Interventions
DRUG

Encorafenib + Binimetinib

Induction treatment with oral encorafenib 450 mg once daily (QD) + binimetinib 45 mg twice daily (BID)(combination: EB) for approximately two months (i.e. 8 weeks)

DRUG

cemiplimab+fianlimab

cemiplimab 350 mg + fianlimab 1600 mg combination every 3 weeks (Q3W)(Combination: CF) administered to patients intravenously (IV) for up to two years.

Trial Locations (18)

10003

RECRUITING

Hospital Universitario San Pedro de Alcántara, Cáceres

15006

RECRUITING

Complejo Hospitalario Universitario A Coruña, A Coruña

20014

RECRUITING

Onkologikoa (Donostia), Donostia / San Sebastian

28007

NOT_YET_RECRUITING

Hospital Universitario Gregorio Marañon, Madrid

28034

RECRUITING

Hospital Universitario Ramón y Cajal, Madrid

28040

RECRUITING

Hospital Clinico San Carlos, Madrid

28222

RECRUITING

Hospital Universitario Puerta del Hierro, Majadahonda

29010

RECRUITING

Hospital Regional Universitario de Málaga, Málaga

30120

RECRUITING

Clinico Universitario Virgen de la Arrixaca, Murcia

39008

RECRUITING

Hospital Universitario Marqués de Valdecilla, Santander

41009

RECRUITING

Hospital Virgen de la Macarena (Sevilla), Seville

46010

RECRUITING

Hospital Clínico Universitario Valencia., Valencia

46014

RECRUITING

Hospital General Universitario de Valencia, Valencia

08028

RECRUITING

Quiron Dexeus - IOR, Barcelona

08035

RECRUITING

Hospital Universitario Vall d´Hebron, Barcelona

08036

RECRUITING

Hospital Clínic de Barcelona, Barcelona

08908

RECRUITING

Instituto Catalán de Oncología - Hospital Duran i Reynals, Barcelona

09006

RECRUITING

Hospital Universitario de Burgos, Burgos

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

collaborator

MFAR

OTHER

collaborator

Pierre Fabre Laboratories

INDUSTRY

lead

Grupo Español Multidisciplinar de Melanoma

OTHER