Induction and Maintenance Treatment With PARP Inhibitor and Immunotherapy in HPV-negative HNSCC

Summary

Participation Requirements

Description

The entire patient population will receive the following treatment: Niraparib 200 mg/day: day -49 to day -21; Dostarlimab 500 mg iv: day -49 and day -28; At day -21, clinical evaluation will be performed and the patient will be directed to surgery with exclusion from the study in case of progressive...

The entire patient population will receive the following treatment: Niraparib 200 mg/day: day -49 to day -21; Dostarlimab 500 mg iv: day -49 and day -28; At day -21, clinical evaluation will be performed and the patient will be directed to surgery with exclusion from the study in case of progressive disease. Radiological assessment will be performed according to the physician's judgement. If no clinical evidence of disease progression, the following schedule will be carried out: Niraparib 200 mg/day day -21 to day -7 Dostarlimab 500 mg iv: day -7 Clinical and radiological evaluation with Diffusion Weighted Imaging Magnetic Resonance Imaging (DWI MRI) of the disease at day -1 (± 3 days); Surgery (original margin) day 0 (± 3 days, within 72 hours from radiological assessment); Following surgery, patients included in the study will undergo standard postoperative (chemo)radiotherapy according to pathologic report. Furthermore, the following schedule will be carried out, in a period comprised between 2 and 6 weeks after the end of radiation therapy: Maintenance Niraparib, 200 mg/day for 6 months Maintenance Dostarlimab, 500 mg iv q3W for the first four cycles and 1000 mg iv Q6W thereafter for 3 months. Before starting this adjuvant treatment phase, inclusion and exclusion criteria of the protocol should be re-assessed and every patient should meet these criteria. Then the patient will start the follow up period, consisting in clinical visits every 3 months for the first year and every 4 months for the second year, then every year. After this period, the patient will be followed according to clinical practice in each site. In each follow up, clinical evaluation with fiberendoscopic assessment will be carried out; moreover, radiological imaging with MRI will be performed every other visit. CT scan of abdomen and thorax or PET/CT will be requested at 12 and 24 months after treatment end. In any case, radiological exams will be requested in case of any doubts of recurrence or late toxicity.

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