Exploring the Addition of Nivolumab to Platinum-Gemcitabine for Recurrent or Metastatic Nasopharyngeal Cancer (NRG-HN007)

October 12 2020

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

NRG Oncology activated the NRG-HN007 trial in September 2020. This phase III study will be comparing platinum-gemcitabine with or without the addition of the immunotherapy drug nivolumab for patients with recurrent or metastatic nasopharyngeal cancer to see if the addition of nivolumab can help to improve overall survival.

“72,987 nasopharyngeal cancer-related deaths were reported worldwide in 2018 according to GLOBOCAN. Currently, patients are treated with platinum-based chemotherapy as the standard of care, however the median OS of this disease in the metastatic setting is on average 12 to 15 months following treatment,” stated Brigette B. Y. Ma, MD, of the Chinese University of Hong Kong and the Principal Investigator of NRG-HN007. “Our goal in NRG-HN007 is to find out if nivolumab can improve the efficacy of platinum-based chemotherapy similar to the outcomes with the addition of pembrolizumab in the KEYNOTE-048 study for other types of head and neck cancer.”

In addition to the primary endpoint of overall survival, researchers will also be comparing patterns of failure, toxicity, objective tumor response, progression-free survival and quality of life between treatment arms.

Patients on the trial will be stratified by their disease location, Zubrod or ECOG performance status and any prior platinum-gemcitabine therapy. Next, patients will be randomly assigned to one of the two treatment arms. Patients on treatment Arm 1 will receive a combination of platinum (cisplatin or carboplatin) and gemcitabine chemotherapy with the added nivolumab. Patients on treatment Arm 2 will receive the same platinum-gemcitabine chemotherapy without nivolumab.

Learn more about this trial on ClinicalTrials.gov

Access the protocol documents and materials on CTSU.org

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