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

We propose a window of opportunity trial to evaluate safety and efficacy of a short course of the study combination, composed by an Anti-PD-1 monoclonal antibody (Dostarlimab (TSR-042)) and a PARPi (Niraparib). The study population will be surgically resectable, HPV-negative (defined by p16 negative status) locally advanced HNSCC. Maintenance treatment will be then delivered, so to better integrate the therapeutic benefits of this drug combination. Response to neoadjuvant treatment will be evaluated by the rate of major pathologic response, morphologic, and functional imaging (MRI with funct

Trial Details

NCT ID
NCT04681469
Phase
PHASE2
Sponsor
Gruppo Oncologico del Nord-Ovest
Status
RECRUITING
Cancer Type
HPV Positive Head and Neck Cancer
Interventions
  • Niraparib
Locations (sample)
  • Brescia, Italy|45.53558,10.21472

Key Eligibility Criteria

  • Patients of both genders, aged ≥18 years;
  • Signed written informed consent;
  • Primary histologically proven p16 negative squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx amenable to surgery with c…
  • Clinical stage III-IV(M0) according to the VIII edition of AJCC staging system; recurrent/metastatic HNSCC, or previously treated HNSCC with local …

For full eligibility, visit ClinicalTrials.gov.

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