Encorafenib and Binimetinib Before Local Treatment in Patients With BRAF Mutant Melanoma Metastatic to the Brain

PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

July 18, 2019

Primary Completion Date

October 10, 2022

Study Completion Date

July 31, 2023

Conditions
Metastatic MelanomaBrain Metastases
Interventions
DRUG

encorafenib

"Encorafenib 75mg and 50mg (capsules) for a 450mg daily for oral administration during 56 days and after local radiation treatment.~If no progression of disease progression (PD) is reported, treatment will continue until PD, unacceptable toxicity or death."

DRUG

binimetinib

Binimetinib 15mg (tablets) for a 45mg/12 hours for oral administration during 56 days and after local radiation treatment.

RADIATION

Whole brain radiation therapy

"The whole brain planning target volume (PTV) will receive 30 Gy in 10 fractions.~Treatment will be delivered once daily, 5 fractions per week, over 2 to 2.5 weeks."

RADIATION

Radiosurgery/stereotactic radiosurgery

"Dose selection must be based on previously published Radiation Therapy Oncology Group (RTOG) data, with dose modification left up to the treating physician. The total dose will depend on the size of the metastatic lesion(s) and proximity to critical structures.~Suggested doses are as follow: 1 fraction x 15-25 Gy; 3 fractions x 9-11 Gy; 5 fractions x 6-7 Gy; or 6 fractions x 5-6 Gy.~For GTV \> 20 mm hypofractionated stereotactic radiotherapy could be preferred. Treatment will be delivered once daily, alternate-day, 3 fractions per week."

Trial Locations (21)

27003

Hospital Lucus Augusti, Lugo

28034

Hospital Universitario Ramón y Cajal, Madrid

30120

Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar

Unknown

Hospital Universitario Son Espases, Palma de Mallorca

Hospital Universitario Marqués de Valdecilla, Santander

Hospital Universitario Quirón Dexeus, Barcelona

Complejo Hospitalario Universitario Insular de Canarias, Las Palmas de Gran Canaria

Hospital Clínic de Barcelona, Barcelona

Hospital del Mar, Barcelona

Hospital Universitario Reina Sofía, Córdoba

H. U. Gregorio Marañón, Madrid

Hospital Clínico San Carlos, Madrid

Hospital Universitario La Paz, Madrid

Hospital Regional Universitario de Málaga, Málaga

Clínica Universidad de Navarra, Pamplona

Hospital Universitario Virgen Macarena, Seville

Hospital General Universitario de Valencia, Valencia

Hospital Universitario y Politécnico La Fe, Valencia

Hospital Miguel Servet, Zaragoza

08908

Institut Català d'Oncología Hospitalet, Barcelona

08035

Hospital Universitari Vall d'Hebron, Barcelona

All Listed Sponsors
collaborator

Pierre Fabre Medicament

INDUSTRY

collaborator

MFAR

OTHER

lead

Grupo Español Multidisciplinar de Melanoma

OTHER

NCT03898908 - Encorafenib and Binimetinib Before Local Treatment in Patients With BRAF Mutant Melanoma Metastatic to the Brain | Biotech Hunter | Biotech Hunter