135
Participants
Start Date
February 11, 2019
Primary Completion Date
July 31, 2023
Study Completion Date
December 31, 2024
Ipilimumab 5 MG/ML
Ipilimumab will be administered on day 1 of each cycle every 3 weeks. In arm 3, ipilimumab should be started at least 2 weeks but no later than 120 days after surgical castration or the first dose of LHRH analogue. Patients should receive 2 doses of ipilimumab (6 weeks). It will be followed, 3 weeks later, by 3 cycles of docetaxel and by 2 additional doses of ipilimumab and 3 more cycles of docetaxel. Four weeks later, Nivolumab will be administered on day 1 every 2 weeks until a maximum of 24 doses (48 weeks)
Nivolumab 10 MG/ML
Nivolumab will be administered every 2 weeks, until clinical progression or a maximum of 24 doses. Nivolumab should be started 4 weeks after the last dose of docetaxel, providing all the adverse effects have recovered, as if a new cycle of docetaxel were to be administered
Docetaxel
"Docetaxel should be given on day 1 every 21 days, for up to 6 cycles (1 cycle = 21 days). Docetaxel should be started within 7 working days from the date of randomization in the arm 1 and 2.~In arm 3, docetaxel will be given 3 weeks after the last dose of the previous treatment, providing all the side effects are grade ≤1."
ADT (androgen deprivation therapy)
Androgen deprivation therapy per the standard of care
Hospital San Pedro de Alcántara, Cáceres
Hospital General de Ciudad Real, Ciudad Real
Hospital General, Materno E Infantil Reina, Córdoba
Hospital Universitari de Girona Dr. Josep Trueta, Girona
Hospital Universitario Lucus Augusti, Lugo
Hospital General Universitario Gregorio Marañón, Madrid
Hospital Ramón Y Cajal, Madrid
Hospital Clínico San Carlos, Madrid
Hospital Universitario 12 de Octubre, Madrid
Hospital Universitario Infanta Sofía, San Sebastián de los Reyes
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda
Complejo Hospitalario de Navarra, Pamplona
Hospital Universitario Central de Asturias, Oviedo
Hospital Universitario Alvaro Cunqueiro, Vigo
Hospital Virgen Del Rocío, Seville
Hospital Nuestra Señora de Valme, Seville
Hospital Virgen Macarena, Seville
Hospital Virgen de La Salud, Toledo
Fundación Instituto Valenciano de Oncología, Valencia
Consorcio Hospital General Universitario de Valencia, Valencia
Hospital Arnau de Vilanova, Valencia
Hospital de Basurto, Bilbao
Hospital Son Llatzer, Palma de Mallorca
Hestia Duran I Reynals, L'Hospitalet de Llobregat
Hospital Sant Joan de Deu (Althaia Manresa), Manresa
Hospital de Sabadell, Sabadell
Hospital Del Mar, Barcelona
Hospital Universitari Vall D'Hebron, Barcelona
Hospital Clínic de Barcelona, Barcelona
Hospital Universitario de Burgos, Burgos
Collaborators (1)
Syntax for Science, S.L
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Spanish Oncology Genito-Urinary Group
OTHER