West Cancer Center

HEAD AND NECK: OROPHARYNGEAL: EARLY STAGE: HPV+ : De-intensified XRT +nivo : NRG-HN005

A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients With Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer

Title

NRG HN-005 (Oropharyngeal De-intensified XRT + nivo)

Study Title

A Randomized Phase II/III Trial of De-Intensified Radiation Therapy for Patients With Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer

Site Link

NCT03952585

Malignancy

Head and Neck cancer, oropharyngeal cancer, papillary squamous cell cancer

Stage

Stage 2

Disease Setting

Chemo/XRT

Line Of Therapy

Definitive chemoradiation

Investigational Agent

De-instensified XRT, nivolumab

Drug Class

Noam VanderWalde, MD

Sponsor

NRG Cooperative Group

Phase

Phase 3

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Squamous cell cancer (including papillary squamous cell and basaloid, but not neuroendocrine) of the oropharynx.
Measurable disease at primary site or nodal stations
P16-positive based on local IHC staining
- If p16 equivocal, HPV DNA is acceptable
Clinical stage T1-2N1M0 or T3N0-1M0. Diagnostic w/u negative for mets
Lifetime cumulative history of smoking cannot exceed 10 years
ECOG PS 0-1
No oral cavity, hypopharynx, or larynx cancer
No supraclavicular nodes
No prior XRT for H+N CA, no prior PD-1 therapy

Objective

Primary
- PFS
- QOL
Secondary
- Locoregional failure
- Distant failure
- OS
- SAfety
- QOL at 24 months

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Squamous cell, HPV positive

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes