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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
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
Conditions
Interventions
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