OncoMatch/Clinical Trials/NCT05784012

Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma

Is NCT05784012 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Dostarlimab and Niraparib for head and neck squamous cell carcinoma.

Phase 1/2RecruitingGrupo Español de Tratamiento de Tumores de Cabeza y CuelloNCT05784012Data as of May 2026

Treatment: Dostarlimab · Niraparib · cisplatin plus radiotherapy · Niraparib — Multi-center, open-label, non-randomized, non-comparative two-cohort study for patients with locally-advanced squamous cell carcinoma arising from the larynx, hypopharynx, oropharynx (Stage III, IVA and IVB according to 8th TNM/AJCC ed.) and oral cavity (unresectable, stage IVB according to 8th TNM/ American Joint Committee on Cancer (AJCC) ed.) who are candidates for definitive radiotherapy plus cisplatin (Cohort A) or as single-modality (in cisplatin unfit patient population) (Cohort B) and will receive dostarlimab and niraparib in combination pre-, during and post- radiation. Study has three parts: 1. Neoadjuvant phase (immune-conditioning phase): patients will receive 1 dose of dostarlimab + niraparib from day -14 prior to radiotherapy (up to 48h prior to radiotherapy (RT) in Cohort A and until RT in Cohort B). 2. Concurrent phase (radiosensitization): patients will receive definitive radiotherapy (70Gy in 35 fractions) with concurrent cisplatin (Cohort A) or with concurrent niraparib (Cohort B). 3. Maintenance: Following radiotherapy, patients will receive adjuvant dostarlimab plus niraparib until week 48 (37 cycles) in both cohorts.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Disease stage

Required: Stage III, IVA, IVB (UICC/AJCC 8th Edition)

Excluded: Stage I, II

Stage III HPV-related oropharyngeal carcinoma OR Stage III, IVA and IVB HPV-unrelated oropharyngeal, laryngeal or hypopharyngeal carcinomas. Stage IVB oral cavity squamous cell carcinomas may be eligible upon consultation with Sponsor if considered unresectable as per treating surgeon and multidisciplinary tumor board. Early stages, defined as stage I-II according to Union for International Cancer Control (UICC) / American Joint Committee on Cancer (AJCC) 8th Edition staging in any localization, and including HPV-related and non-related [excluded].

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: systemic therapy

Exception: diagnostic biopsy

Any previous treatment for current head and neck cancer including systemic therapy, radiotherapy and/or surgery (except for a diagnostic biopsy)

Cannot have received: radiotherapy

Any previous radiation to the head and neck region that would result in overlap of fields for the current study

Cannot have received: radiotherapy

Any previous radiotherapy treatment encompassing > 20 % of the bone marrow within 2 weeks or any radiotherapy within 1 week prior to Day 1 of protocol therapy

Cannot have received: PARP inhibitor

Any previous treatment with poly-ADP ribose polymerase (PARP)...inhibitors

Cannot have received: anti-PD-L1 therapy

Any previous treatment with...programmed death ligand (PD-L1)...inhibitors

Cannot have received: anti-CTLA-4 therapy

Any previous treatment with...cytotoxic T lymphocyte associated protein (CTLA-4) inhibitors

Lab requirements

Blood counts

Absolute neutrophils > 1.5 x 10^9/L; Platelets > 100 x 10^9/L; Hemoglobin > 90 g/L

Kidney function

Cohort A: Creatinine clearance > 60 mL/min; Cohort B: Creatinine clearance >30 but <60 mL/min

Liver function

Bilirubin < 1.5 x ULN; AST and ALT < 2.5 x ULN

Cardiac function

Cohort A: Not presenting with cardiovascular disease: NYHA class II or higher, ischemic cardiovascular/cerebrovascular event in past 12 months, clinically-significant peripheral arterial vasculopathy; Exclusion: unstable angina, congestive heart failure ≥ NYHA Class 2, QTc >480 ms, LVEF < 50

Patient must have adequate organ function as determined by the following: Hematology...Biochemistry...Specific criteria for Cohort A...Specific criteria for Cohort B...Any of the following cardiac abnormalities: unstable angina pectoris, congestive heart failure ≥ NYHA Class 2, QTc >480 milliseconds, known LVEF < 50.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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