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)

NCT06725368 Phase 2 RECRUITING

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.

Details

Lead sponsor	Centre Paul Strauss
Phase	Phase 2
Status	RECRUITING
Enrolment	46
Start date	2025-01-24
Completion	2032-01

Conditions

• Head and Neck Cancer

Interventions

• PCC

Primary outcomes

• Objective Response Rate — every 90 days up to 12 months
  Best radiological response according to RECIST 1.1 criteria Number of patients who had an objective response within 12 months CT or MRI (PET scan is not validated for response evaluation) The evaluation is carried out by the investigator.

Countries

France