OncoMatch/Clinical Trials/NCT04681469
Induction and Maintenance Treatment With PARP Inhibitor and Immunotherapy in HPV-negative HNSCC
Is NCT04681469 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Niraparib for head and neck squamous cell carcinoma.
Treatment: Niraparib — 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 functional evaluation -DWI). We anticipate that neoadjuvant and maintenance PARPi plus immunotherapy treatment could lead to a reduction of loco-regional recurrence (LRR) and distant metastasis (DM) rates in such a high-risk population. Furthermore, the window of opportunity portion of this trial will allow in vivo acquisition of valuable knowledge on mechanisms of action and primary resistance to Anti-PD-1 monoclonal antibody and PARPi in HNSCC. In this phase of the study, biological specimens will be collected (pre-treatment tumor biopsy, tissues from the surgical specimen, liquid biopsy, blood and saliva samples) as well as functional imaging (MRI).
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: CDKN2A wild-type (p16 negative)
Primary histologically proven p16 negative squamous cell carcinoma ... p16 status will be assessed as surrogate marker for HPV infection only for oropharyngeal cancers. p16 status will be assessed using the CINtec p16 Histology assay ... with strong and diffuse nuclear and cytoplasmic staining in at least 70% of cells used as the cutpoint for positivity.
Disease stage
Required: Stage III, IV(M0)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: local or systemic treatment for HNSCC
Patient has received prior local or systemic treatment for HNSCC
Lab requirements
Blood counts
absolute neutrophil count ≥ 1500, hemoglobin ≥ 9.0 gram/deciliter (g/dl), platelet count ≥ 100,000
Kidney function
serum creatinine ≤ 1.5 times institutional upper limit of normal or creatinine clearance ≥ 60 milliliters per minute (ml/min) according to cockroft-gault formula, or local institutional standard method
Liver function
total bilirubin ≤1.5 times institution's upper limit of normal, ast/sgot and alt/spgt ≤ 2.5 times institutional upper limit of normal, albumin ≥ 2.0 g/dl
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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