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

NCT05784012 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-03-13

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • MFAR

    collaborator OTHER

  • Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

    lead OTHER

Principal Investigators

  • Marc Oliva, M.D. · Institut Català D´Oncologia (ICO) Hospitalet de Llobregat

  • Ricard Mesia, M.D. Ph.D. · Institut Català d''Oncologia (ICO) Badalona

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-08
Primary Completion
2027-09-30
Completion
2029-03-31

Countries

  • Spain

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05784012 on ClinicalTrials.gov