A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 21
SponsorNational Cancer Institute (NCI)

About this trial

This phase II trial tests effects of nivolumab in combination with chemotherapy drugs prior to radiation therapy patients with nasopharyngeal carcinoma (NPC). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Researchers want to find out what effects, good and/or bad, adding nivolumab to chemotherapy has on patients with newly diagnosed NPC. In addition, they want to find out if children with NPC may be treated with less radiation therapy and whether this decreases the side effects of therapy.

Eligibility criteria

Qualifiers

Patients must be ≤ 21 years of age at the time of study enrollment

Newly diagnosed American Joint Committee on Cancer (AJCC) stage II-IV nasopharyngeal carcinoma (NPC)

Patients must have had histologic verification of the malignancy at original diagnosis

Although submission of tumor tissue for the molecular characterization initiative is not required for eligibility, it is strongly recommended

Disqualifiers

Patients who received prior radiotherapy to the head or neck

Patients who received prior chemotherapy or radiation for the treatment of any cancer in the last 3 years. These patients must also be in remission

Patients with a diagnosis of immunodeficiency

Patients with an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive agents). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.

Trial design

Treatments tested in this trial

  • Biopsy Procedure
  • Biospecimen Collection
  • Chest Radiography
  • Cisplatin
  • Computed Tomography
  • Echocardiography Test
  • Electronic Health Record Review
  • Fluciclovine F18
  • Gemcitabine
  • Magnetic Resonance Imaging
  • Multigated Acquisition Scan
  • Nivolumab
  • Positron Emission Tomography
  • Quality-of-Life Assessment
  • Questionnaire Administration
  • Radiation Therapy
  • X-Ray Imaging

Treatment groups

50 Participants
are divided into 1 treatment group