NCT05784012

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

Phase Ib/II Non-randomized Non-comparative Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Grupo Español de Tratamiento de Tumores de Cabeza y Cuello · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

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

Timeline

• Start date: 2023-11-08
• Primary completion: 2027-09-01
• Completion: 2029-03-01
• First posted: 2023-03-24
• Last updated: 2025-03-13

Locations

5 sites across 1 country: Spain