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
Terminated
Date Opened To Accrual
September 08 2020
Date Closed to Accrual
October 28 2021
Date of Study Termination
August 15 2023
Disease Site
Head and Neck [HN]
Head and Neck
Phase
III
Developmental Therapeutics
No
Primary Objective
To determine if adding nivolumabto 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
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.