48
Participants
Start Date
July 18, 2019
Primary Completion Date
October 10, 2022
Study Completion Date
July 31, 2023
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."
binimetinib
Binimetinib 15mg (tablets) for a 45mg/12 hours for oral administration during 56 days and after local radiation treatment.
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."
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."
Hospital Lucus Augusti, Lugo
Hospital Universitario Ramón y Cajal, Madrid
Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar
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
Institut Català d'Oncología Hospitalet, Barcelona
Hospital Universitari Vall d'Hebron, Barcelona
Pierre Fabre Medicament
INDUSTRY
MFAR
OTHER
Grupo Español Multidisciplinar de Melanoma
OTHER