NRG-HN008

Closed to Accrual & Treatment

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Phase I Trial with Expansion Cohort of DNA-PK Inhibition and IMRT in Cisplatin-Ineligible Patients with Stage 3-4 Local-Regionally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC)

Principal Investigator

Maura Gillison

Co-Principal Investigator(s)

Michael Samuels, MD

Status

Closed to Accrual & Treatment

Open to Accrual

December 10, 2020

Temporarily Closed to Accrual

November 3, 2022

Open to Accrual

March 13, 2023

Temporarily Closed to Accrual

April 30, 2024

Open to Accrual

May 20, 2024

Closed to Accrual

January 6, 2025

Closed to Accrual & Treatment

March 5, 2025


Disease Site

Head and Neck [HN] Head and Neck

Phase

I

Developmental Therapeutics

No

Primary Objective

To determine the recommended phase
2 dose (RP2D) of M3814 (peposertib) when given in combination with IMRT.

Patient Population

Pathologically (histologically) proven diagnosis of HNSCC
of the oral cavity, oropharynx, larynx, or hypopharynx prior to registration; 
patients with oropharynx cancer need p16 determination by immunohistochemistry.  Oral cavity, larynx, hypopharynx, or p16-negative oropharynx cancer must be  stages T1-2N2 -3 or T3N1-3 or T4N0-3; p16-positive oropharynx cancer patients,
stages T4N0-3 or T1-3N2-3.

Target Accrual

42

Patient Study Webpage

There is no available patient study webpage available for this trial at this time.