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