RecruitingPhase 2NCT06725368

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

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)

Sponsor

Centre Paul Strauss

Enrollment

46 participants

Start Date

Jan 24, 2025

Study Type

INTERVENTIONAL

Conditions

Head and Neck Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination chemotherapy regimen — carboplatin, paclitaxel, and cetuximab (PCC) — as a second-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma whose cancer progressed after immunotherapy (pembrolizumab). **You may be eligible if...** - Age 18 or older - Have a confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx - Cancer has returned or spread (recurrent/metastatic) - Previously received pembrolizumab (with or without chemotherapy) as first-line treatment, and your cancer progressed - Have adequate organ function **You may NOT be eligible if...** - Have received more than one prior line of treatment for recurrent/metastatic disease - Have severe heart, kidney, or liver problems - Are pregnant or breastfeeding - Have nasopharyngeal cancer (different type) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPCC

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.