RecruitingStage II Nasopharyngeal Carcinoma AJCC v8Stage III Nasopharyngeal Carcinoma AJCC v8Stage IV Nasopharyngeal Carcinoma AJCC v8

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

Eligible age

Up to 21 yrs

Accepts

All genders

Locations

36 states

Healthy volunteers

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About this study

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.

Sponsor: National Cancer Institute (NCI)

You may qualify if…

✓ 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
✓ 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
✓ Patients must have a Lansky (for patients ≤ 16 years of age) or Karnofsky (for patients \> 16 years of age) performance status score of ≥ 60%
✓ Peripheral absolute neutrophil count (ANC) ≥ 1000/uL (within 7 days prior to start of protocol therapy)

You may not qualify if…

✕ 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.
✕ Note: Patients with well-controlled asthma and no need for systemic steroids for the treatment of asthma in the last 12 months will not be excluded
✕ Patients with a condition requiring systemic treatment with either corticosteroids (\> 0.25 mg/kg (10 mg) daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses \> 0.25 mg/kg (10 mg) daily prednisone equivalent, are permitted in the absence of active autoimmune disease
✕ Patients with a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
✕ Patients with detectable viral load of human immunodeficiency virus (HIV), hepatitis B or hepatitis C, or active tuberculosis