A Phase III Study of Platinum/Gemcitabine Chemotherapy with or without Nivolumab Immunotherapy as Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer

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Full Title

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-HN007) (CIRB)

Purpose

The usual chemotherapy regimen for advanced nasopharyngeal cancer is either cisplatin or carboplatin plus the drug gemcitabine. In this study, researchers are assessing the effectiveness of adding nivolumab to the usual chemotherapy for patients with recurrent or metastatic nasopharyngeal cancer. Nivolumab works by boosting the ability of the immune system to find and kill cancer cells.

Patients will be randomly assigned to receive cisplatin or carboplatin and gemcitabine with or without nivolumab. All of these treatments are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have recurrent or metastatic nasopharyngeal cancer.
  • Patients may not have received treatment for metastatic cancer. Any prior therapy for non-metastatic disease must have been completed 6 months or more before receiving the study treatment.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Eric Sherman at 646-608-3776.

Protocol

21-046

Phase

III

Investigator

Co-Investigators