NCT06869473 - Cetuximab Plus Platinum and Taxane-based Chemotherapy, Followed by Avelumab and Cetuximab, as First-line Treatment for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) Patients With a PD-L1 Combined Positive Score (CPS)≥1≤19. | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 20, 2025

Primary Completion Date

August 20, 2027

Study Completion Date

February 20, 2028

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)Recurrent Head and Neck CancerMetastatic Head and Neck Cancer

Interventions

DRUG

Cetuximab/avelumab

"Study Maintenance therapy: AVEC (each cycle every 2 weeks) Cetuximab will be administered at 500 mg/m2 dose (as a 2-hour intravenous infusion) every 2 weeks until disease progression or unacceptable side effects.~Cetuximab will be administered by IV infusion over 120 minutes. The initial dose should be given slowly and speed of infusion must not exceed 5 mg/min.~Avelumab will be administered at 800 mg flat dose (as a 1-hour intravenous fusion) every 2 weeks until disease progression or unacceptable side effects."

Trial Locations (8)

20089

NOT_YET_RECRUITING

Irccs Humanitas Research Hospital, Rozzano

20133

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori (INT) di Milano, Milan

50134

RECRUITING

Azienda Ospedaliero-Universitaria Careggi, Florence

80131

RECRUITING

Irccs Fondazione G. Pascale, Napoli

80138

NOT_YET_RECRUITING

AOU Luigi Vanvitelli, Napoli

95123

NOT_YET_RECRUITING

"Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-S. Marco", Catania

09121

NOT_YET_RECRUITING

"Ospedale Oncologico A. Businco ARNAS BROTSU", Cagliari

00189

NOT_YET_RECRUITING

Azienda Ospedaliero-Universitaria Sant'Andrea, Roma