NCT05784012View on ClinicalTrials.gov

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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

November 8, 2023

Primary Completion Date

September 30, 2027

Study Completion Date

March 31, 2029

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
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).

Trial Locations (5)

31008

RECRUITING

Complejo Hospitalario de Navarra, Pamplona

08916

RECRUITING

Institut Catalá d'Oncologia (ICO) BADALONA, Badalona

08035

RECRUITING

Hospital Universitario Valle Hebron, Barcelona

08036

RECRUITING

Hospital Clinic de Barcelona, Barcelona

08908

RECRUITING

Institut Catalá d'Oncologia (ICO) Hospitalet, L'Hospitalet de Llobregat

Sponsors

Collaborators (1)

GlaxoSmithKline
All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

collaborator

MFAR

OTHER

lead

Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

OTHER

NCT05784012 - Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma | Biotech Hunter | Biotech Hunter