Study of Cetuximab Plus/Minus Weekly Paclitaxel After Progression To First-Line Pembrolizumab Plus Platinum-5FU in Subjects With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck.

PHASE2RecruitingINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

June 18, 2025

Primary Completion Date

October 31, 2028

Study Completion Date

October 31, 2028

Conditions
Recurrent / Metastatic Head and Neck Squamous Cell Carcinoma
Interventions
DRUG

Cetuximab

Cetuximab 250 mg/m2 will be administered as an intravenous infusion over 60 minutes. Cetuximab loading dose is 400 mg/m2 infusion and will be administered over 120 minutes. During maintenance, cetuximab at 500 mg/m2 will be administered as an intravenous infusion over 120 minutes.

DRUG

Paclitaxel

Paclitaxel at a dose of 80 mg/m² will be administered after cetuximab as an intravenous infusion over 60 minutes weekly.

Trial Locations (11)

15009

RECRUITING

Centro Oncológico de Galicia (La Coruña), A Coruña

28031

RECRUITING

Hospital Infanta Leonor (Madrid), Vallecas

28040

RECRUITING

Hospital Clínico San Carlos, Madrid

28041

RECRUITING

Hospital Universitario 12 de Octubre (Madrid), Madrid

31008

RECRUITING

Complejo Hospitalario de Navarra (Pamplona), Pamplona

37007

RECRUITING

Complejo Hospitalario de Salamanca (Salamanca), Salamanca

38320

RECRUITING

Hospital Universitario de Canarias (La laguna), San Cristóbal de La Laguna

39008

RECRUITING

Hospital Universitario Marqués de Valdecilla (Santander), Santander

41013

RECRUITING

Hospital Universitario Virgen del Rocío (Sevilla), Seville

41014

RECRUITING

Hospital Universitario Virgen de Valme (Sevilla), Seville

08908

RECRUITING

Instituto Catalán de Oncología - Hospital Duran i Reynals, Barcelona

All Listed Sponsors
lead

Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

OTHER

NCT06856213 - Study of Cetuximab Plus/Minus Weekly Paclitaxel After Progression To First-Line Pembrolizumab Plus Platinum-5FU in Subjects With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck. | Biotech Hunter | Biotech Hunter