141
Participants
Start Date
June 3, 2020
Primary Completion Date
September 1, 2023
Study Completion Date
March 21, 2024
Nivolumab + Paclitaxel
"Combination treatment: Nivolumab 240 mg will be administered via IV infusion every 2 weeks. Paclitaxel 80mg/m2 will be administered via IV infusion weekly. After 12 weeks from the start of the combined treatment paclitaxel will be stopped.~Maintenance treatment with nivolumab 480 mg every 4 weeks will start two weeks after the last administration of nivolumab 240 mg. Once nivolumab is administered at 480 mg, paclitaxel can no longer be administered.~Nivolumab will be continued alone until disease progression, unacceptable toxicity or withdrawal of consent up to a maximum of 24 months."
Cetuximab + Paclitaxel
"Combination treatment: Cetuximab 250 mg/m2 (first dose of 400 mg/m2) administered via IV infusion weekly plus weekly paclitaxel (80 mg/m2) administered via IV infusion.~After 12 weeks from the start of the combined treatment paclitaxel will be stopped and weekly cetuximab will be continued alone until disease progression, unacceptable toxicity or withdrawal of consent up to a maximum of 24 months."
Centro Oncoloxico de Galicia, A Coruña
Hospital Universitari de Girona Dr. Josep, Girona
Hospital Universitario Virgen de las Nieves, Granada
Hospital Universitario Donostia- Donostia Unibertsitate Ospitalea, San Sebastián
Hospital Universitario Lucus Augusti, Lugo
Hospital Clínico San Carlos, Madrid
Hospital Universitario Regional de Málaga, Málaga
Complejo Hospitalario de Navarra, Pamplona
Complejo Asistencial Universitario de Salamanca, Salamanca
Hospital Universitario Marqués de Valdecilla, Santander
Hospital Universitario Virgen del Rocío, Seville
Hospital Virgen de la Salud, Toledo
Hospital Clínico Universitario de Valencia, Valencia
Hospital Universitario y Politécnico la Fe, Valencia
Hospital Clínico Universitario Lozano, Zaragoza
Hospital Universitario Miguel Servet, Zaragoza
Hospital Universitari Germans Trias i Pujol de Badalona, Badalona
Hospital Universitari Vall d'Hebron, Barcelona
Hospital Clínic de Barcelona, Barcelona
Institut Català D´Oncologia- Hospital Duran i Reynals, Barcelona
Hospital 12 de Octubre, Madrid
Collaborators (1)
Bristol-Myers Squibb
INDUSTRY
Apices Soluciones S.L.
INDUSTRY
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
OTHER