West Cancer Center

HEAD AND NECK: LOCALLY ADVANCED: CHEMORAD+/-PD-L1: JAVELIN HEAD+NECK

A randomized double-blind phase 3 study of avelumab in combination with standard of care chemoradiotherapy (cisplatin plus definitive radiation therapy) versus standard of care chemoradiotherapy in the front-line treatment of patients with locally advanced squamous cell carcinoma of the head and neck

Title

Pfizer B9991016 (JAVELIN HEAD AND NECK)

Study Title

Site Link

NCT02952586

Malignancy

Head and Neck Cancer, Oral cavity, oropharynx, larynx, hypopharynx, SCCHN

Stage

Stage 3

Disease Setting

Locally advanced

Line Of Therapy

1st

Investigational Agent

Avelumab

Drug Class

PD-L1 inhibitor

Moon Fenton

Sponsor

Pfizer

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Histological diagnosis of squamous cell carcinoma of hte oral cavity, oropharynx, hypopharynx, or larynx
Eligible for the following stages:
- For HPV negative disease
  - Stage III, IVA, or IVB
- For HPV positive disease that is not oropharyngeal
  - Stage III, IVA, or IVB
- For oropharyngeal HPV positive disease
  - T4 or N2c or N3
No prior therapy for advanced stage SCCHN, must be eligible for CRT with curative intent
ECOG PS 0-1
No prior immunotherapy
No other malignancy within 5 years except CIS or non-melanoma skin cancer
No active autoimmune disease
No severe cardiac issues with preiouvs 6 months
No known HBV/HCV/HIV

Objective

Primary- PFS; Secondary- OS, Local-regional control, Distant metastatic failure, ORR, Path CR, safety, PK, biomarker

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Squamous cell carcinoma

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes