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Neoadjuvant Immunoradiotherapy in Head & Neck Cancer

NCT03247712 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-07-10

No results posted yet for this study

Summary

The purpose of this study is to test the safety of neoadjuvant immunoradiotherapy as a safe means of down-staging Head and Neck Squamous Cell Carcinoma (HNSCC) prior to surgical resection.

Conditions

Interventions

DRUG

Nivolumab

Nivolumab 240mg IV q2wks or 480mg IV q4wks

PROCEDURE

Surgical Resection

Surgical Resection of Tumor

RADIATION

Radiation (5 days)

8Gy x 5 (Mon-Fri) GTV+3mm

RADIATION

Radiation (3 days)

8Gy x 3 (Monday, Wednesday, Friday) GTV+3mm

Sponsors & Collaborators

  • Providence Cancer Center, Earle A. Chiles Research Institute

    collaborator OTHER

  • Providence Health & Services

    lead OTHER

Principal Investigators

  • Rom Leidner, MD · Providence Health and Services

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2020-02-13
Completion
2026-12-31
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 NCT03247712 on ClinicalTrials.gov