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RECRUITING
NCT06725368
PHASE2

Carboplatin + Paclitaxel + Cetuximab (PCC) After Failure of Pembrolizumab +/- First-line Chemotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Sponsor: Centre Paul Strauss

View on ClinicalTrials.gov

Summary

This study targets an adult population of patients with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), who have failed after a first line of treatment with pembrolizumab associated or not with chemotherapy and having an indication for a second line of treatment. Patients will be recruited in France in medical oncology departments. The main objective is to evaluate the objective response rate of PCC in patients with HNSCC with locoregional and/or distant 2nd line metastatic disease after failure of pembrolizumab +/- chemotherapy. The secondary objectives of the study are to evaluate other efficacy parameters by monitoring the progression of the disease, the tolerance of the treatment by collecting adverse effects and quality of life. The duration of participation in the research is 12 months.

Official title: Carboplatin + Paclitaxel + Cetuximab (PCC) After Failure of Pembrolizumab +/- First-line Chemotherapy in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: CARPACCIO (CARboplatin PAClitaxel Cetuximab IO Immuno-oncology)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2025-01-24

Completion Date

2032-01

Last Updated

2025-12-23

Healthy Volunteers

No

Interventions

DRUG

PCC

PCC protocol (Paclitaxel - Carboplatin - Cetuximab) by intravenous injection for 16 cycles. 1 cycle lasts 1 week. The Carboplatin + Paclitaxel administration schedule 3 weeks out of 4, with weekly Cetuximab is authorized. After 16 cycles: maintenance with Cetuximab 500 mg/m2 every 14 days until unacceptable toxicity or progression or death.

Locations (5)

Centre hospitalier Régional de Metz-Thionville

Ars-Laquenexy, France

CHU de Besançon

Besançon, France

Centre Hospitalier de Colmar

Colmar, France

Centre Paul Strauss

Strasbourg, France

Institut de cancérologie de Lorraine

Vandœuvre-lès-Nancy, France