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Neoadjuvant Immunoradiotherapy in Head & Neck Cancer (NIRT 2-HNC)

NCT04938609 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-04-09

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy of neoadjuvant immunoradiotherapy (NIRT) prior to surgery for the treatment of stage III and IVA HPV- HNSCC.

Conditions

Interventions

DRUG

Pembrolizumab

Pembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region.

RADIATION

Stereotactic Body Radiation Therapy (5 days)

8Gy x 3 (Mon-Fri) GTV+3mm

PROCEDURE

Surgical Resection

Surgical Resection of Tumor

Sponsors & Collaborators

  • Providence Cancer Center, Earle A. Chiles Research Institute

    collaborator OTHER

  • Providence Health & Services

    lead OTHER

Principal Investigators

  • R. Bryan Bell, MD, DDS, FACS · Providence Health & Services

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-11
Primary Completion
2027-01-11
Completion
2031-01-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT04938609 on ClinicalTrials.gov