NRG-HN007

An Open-Label, Phase III Study of Platinum-Gemcitabine with or Without Nivolumab in the First-Line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma

Principal Investigator

Brigette Ma, MD

Status

Disease Site

Head and Neck [HN] Head and Neck

Phase

III

Developmental Therapeutics

No

Primary Objective

To determine if adding nivolumab
to platinum-gemcitabine as first-line treatment improves overall survival (OS)
for patients with recurrent and/or metastatic nasopharyngeal carcinoma (NPC).

Patient Population

Pathologically (histologically or cytologically) proven diagnosis of NPC that has recurred at locoregional and/or distant sites prior to registration. For locoregional recurrence, the disease must not be amenable to potentially curative surgery or re-irradiation. The following histological types are accepted: (a) Keratinizing – squamous cell carcinoma; (b) Non-keratinizing – undifferentiated or poorly differentiated.

Target Accrual

316