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

Recruiting now · Phase 2

Conditions studied: Stage II Nasopharyngeal Carcinoma AJCC v8, Stage III Nasopharyngeal Carcinoma AJCC v8, Stage IV Nasopharyngeal Carcinoma AJCC v8

In brief

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.

Key facts

Study ID: NCT06064097
Run by: National Cancer Institute (NCI)
People needed: 50
Starts: 2024-06-25
Expected to finish: 2026-12-31
Last updated by the study team: 2026-08-05

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

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)
Platelet count ≥ 100,000/uL (transfusion independent) (within 7 days prior to start of protocol therapy)
Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m\^2 or (within 7 days prior to start of protocol therapy)
A serum creatinine based on age/sex (within 7 days prior to start of protocol therapy) Age: Maximum serum creatinine (mg/dL)
1 month to < 6 months: 0.4 mg/dL (male); 0.4 mg/dL (female) 6 months to < 1 year: 0.5 mg/dL (male); 0.5 mg/dL (female)
1 to < 2 years: 0.6 mg/dL (male); 0.6 mg/dL (female) 2 to < 6 years: 0.8 mg/dL (male); 0.8 mg/dL (female) 6 to < 10 years 1 mg/dL (male); 1 mg/dL (female) 10 to <13 years: 1.2 mg/dL (male); 1.2 mg/dL (female) 13 to < 16 years: 1.5 mg/dL (male); 1.4 mg/dL (female)
≥ 16 years: 1.7 mg/dL (male); 1.4 mg/dL (female)
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, and (within 7 days prior to start of protocol therapy)
Serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) ≤ 135 U/L* (within 7 days prior to start of protocol therapy)
Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
Shortening fraction of ≥ 27% by echocardiogram, or
Ejection fraction of ≥ 50% by radionuclide angiogram
No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry > 94% if there is clinical indication for determination
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and T-cell count above the lower limit of normal are eligible for this trial
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

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
Patients who have undergone solid organ or allogeneic hematopoietic transplant at any time
Due to risks of fetal and teratogenic adverse events as seen in animal studies, a negative pregnancy test must be obtained in females of childbearing potential, defined as females who are post-menarchal. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Females of childbearing potential that are sexually active must agree to either practice 2 medically accepted highly-effective methods of contraception at the same time or abstain from heterosexual intercourse from the time of signing the informed consent through 5 months after the last dose of nivolumab, 6 months after the last dose of gemcitabine, and 14 months after the last dose of cisplatin, whichever is longer
Males of childbearing potential that are sexually active must agree to either practice a medically accepted highly-effective methods of contraception or abstain from heterosexual intercourse from the time of signing the informed consent through 3 months after the last dose of gemcitabine, and 11 months after the last dose of cisplatin, whichever is longer
Lactating females are not eligible unless they have agreed not to breastfeed their infants starting with the first dose of study therapy through 5 months after the last dose of nivolumab
All patients and/or their parents or legal guardians must sign a written informed consent
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Where it is running

Children's Hospital of Alabama — Birmingham, Alabama, United States (enrolling)
Arkansas Children's Hospital — Little Rock, Arkansas, United States (enrolling)
Kaiser Permanente Downey Medical Center — Downey, California, United States (enrolling)
Phoenix Childrens Hospital — Phoenix, Arizona, United States (enrolling)
Children's Hospital Los Angeles — Los Angeles, California, United States (enrolling)
Valley Children's Hospital — Madera, California, United States (enrolling)
UCSF Benioff Children's Hospital Oakland — Oakland, California, United States (enrolling)
Kaiser Permanente-Oakland — Oakland, California, United States (enrolling)
Rady Children's Hospital - San Diego — San Diego, California, United States (enrolling)
Loma Linda University Medical Center — Loma Linda, California, United States (enrolling)
Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
Connecticut Children's Medical Center — Hartford, Connecticut, United States (enrolling)
Alfred I duPont Hospital for Children — Wilmington, Delaware, United States (enrolling)
Children's National Medical Center — Washington D.C., District of Columbia, United States (enrolling)
UF Health Cancer Institute - Gainesville — Gainesville, Florida, United States (enrolling)
Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States (enrolling)
Nicklaus Children's Hospital — Miami, Florida, United States (enrolling)
Arnold Palmer Hospital for Children — Orlando, Florida, United States (enrolling)
Nemours Children's Hospital — Orlando, Florida, United States (enrolling)
Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States (enrolling)
Saint Joseph's Hospital/Children's Hospital-Tampa — Tampa, Florida, United States (enrolling)
UCSF Medical Center-Mission Bay — San Francisco, California, United States (enrolling)
Lurie Children's Hospital-Chicago — Chicago, Illinois, United States (enrolling)
University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States (enrolling)
Riley Hospital for Children — Indianapolis, Indiana, United States (enrolling)

Full record on ClinicalTrials.gov

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