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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Paul Strauss

About this trial

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 criteria

Qualifiers

Age greater than or equal to 18 years at inclusion

Cytological or histological confirmation of the diagnosis of invasive squamous cell carcinoma of the head and neck

One of the following locations: oral cavity, oropharynx (known p16 status), larynx or hypopharynx

Cancers of unknown primary (CUP) of the head and neck are accepted

Disqualifiers

Other histology

Nasal, paranasal and nasopharyngeal cavities

Symptomatic or active brain parenchymal metastases or leptomeningeal tumors

Grade ≥2 neuropathy

Trial design

Treatments tested in this trial

  • PCC

Treatment groups

46 Participants
are divided into 1 treatment group

Sponsors and collaborators