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

Sponsor
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Study ID
NCT05784012
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dostarlimab — DRUG
    Dostarlimab 500 mg IV every 21 days in neoadjuvant and adjuvant stage.
  • Niraparib — DRUG
    Niraparib 200 or 300mg orally administered QD in neoadjuvant, concurrent with radiotherapy and adjuvant stage until completing week 48.
  • cisplatin plus radiotherapy — DRUG
    In the concurrent phase
  • Niraparib — DRUG
    Niraparib 200 or 300mg orally administered QD (Neoadjuvant and Maintenance stages).

Study Details

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 day -21; niraparib from day -14 prior to radiotherapy (up to 48h prior to radiotherapy (RT) in Cohort A; Cohort B niraparib is uninterrupted until the end of study treatment). 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 Cycle 14 day1(dostarlimab) and day21(niraparib).

Key Dates

Start date
Nov 13, 2023
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2029

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Three stages: Neoadjuvant: single dose of dostarlimab 500 mg intravenously on day -21 and niraparib 200 or 300 mg orally once daily starting on day -14 until 48 hours prior to the start of definitive radiotherapy (day 0). Concurrent: definitive radiotherapy (70 Gy in 35 fractions, 1 fraction per day from Monday to Friday) with concurrent Cisplatin at a dose of 100 mg/m2 intravenously on day 1 of week 1, week 4 and week 7. Maintenance: dostarlimab to be administered as a single infusion dose of 500 mg on day 1 every 21 days from week 11 to week 48. Niraparib will be given once daily at a dose of 200 or 300 mg in cycles of 21 days.
  • Experimental: Cohort B
    Three stages: Neoadjuvant: single dose of dostarlimab 500 mg intravenously on day -21 and niraparib 200 or 300 mg orally once daily starting on day -14 until the start of definitive radiotherapy (day 0). Concurrent: definitive radiotherapy (70 Gy in 35 fractions, 1 fraction per day from Monday to Friday). Niraparib is to be given once daily on a continous basis (200 to 300 mg), from w1 d1 until end of w10 in cycles of 21 days. Maintenance: dostarlimab to be administered as a single infusion dose of 500 mg on day 1 every 21 days from week 11 to week 48. Niraparib will be given once daily on a continous basis at a dose of 200 or 300 mg in cycles of 21 days.

Primary Outcome Measure

1-year disease free survival [ Time Frame: 1 year after the start of the study treatment ]

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