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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT06064097

Registry updated: 2026-10-14
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Description

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.

Interventions

  • Biopsy Procedure (Procedure)
    Undergo tissue biopsy
  • Biospecimen Collection (Procedure)
    Undergo blood and stool sample collection
  • Chest Radiography (Procedure)
    Undergo chest x-ray
  • Cisplatin (Drug)
    Given IV
  • Computed Tomography (Procedure)
    Undergo CT
  • Echocardiography Test (Procedure)
    Undergo ECHO
  • Electronic Health Record Review (Other)
    Ancillary studies
  • Fluciclovine F18 (Other)
    Given IV
  • Gemcitabine (Drug)
    Given IV
  • Magnetic Resonance Imaging (Procedure)
    Undergo MRI
  • Multigated Acquisition Scan (Procedure)
    Undergo MUGA
  • Nivolumab (Biological)
    Given IV
  • Positron Emission Tomography (Procedure)
    Undergo PET
  • Quality-of-Life Assessment (Other)
    Ancillary studies
  • Questionnaire Administration (Other)
    Ancillary studies
  • Radiation Therapy (Radiation)
    Receive radiation therapy
  • X-Ray Imaging (Procedure)
    Undergo dental x-ray

Eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Conditions

Stage II Nasopharyngeal Carcinoma AJCC v8 Stage III Nasopharyngeal Carcinoma AJCC v8 Stage IV Nasopharyngeal Carcinoma AJCC v8

Locations

  • Children's Hospital of Alabama — Birmingham, Alabama, United States
  • Phoenix Childrens Hospital — Phoenix, Arizona, United States
  • Arkansas Children's Hospital — Little Rock, Arkansas, United States
  • Kaiser Permanente Downey Medical Center — Downey, California, United States
  • Loma Linda University Medical Center — Loma Linda, California, United States
  • Children's Hospital Los Angeles — Los Angeles, California, United States
  • Valley Children's Hospital — Madera, California, United States
  • UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
  • Kaiser Permanente-Oakland — Oakland, California, United States
  • Rady Children's Hospital - San Diego — San Diego, California, United States
  • UCSF Medical Center-Mission Bay — San Francisco, California, United States
  • Children's Hospital Colorado — Aurora, Colorado, United States
  • Connecticut Children's Medical Center — Hartford, Connecticut, United States
  • Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
  • Children's National Medical Center — Washington D.C., District of Columbia, United States
  • UF Health Cancer Institute - Gainesville — Gainesville, Florida, United States
  • Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
  • Nicklaus Children's Hospital — Miami, Florida, United States
  • Arnold Palmer Hospital for Children — Orlando, Florida, United States
  • Nemours Children's Hospital — Orlando, Florida, United States
  • Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States
  • Saint Joseph's Hospital/Children's Hospital-Tampa — Tampa, Florida, United States
  • Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta, Georgia, United States
  • Lurie Children's Hospital-Chicago — Chicago, Illinois, United States
  • University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
  • Riley Hospital for Children — Indianapolis, Indiana, United States
  • University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States
  • Children's Hospital New Orleans — New Orleans, Louisiana, United States
  • Maine Children's Cancer Program — Scarborough, Maine, United States
  • Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland, United States
  • Dana-Farber Cancer Institute — Boston, Massachusetts, United States
  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States
  • Mayo Clinic in Rochester — Rochester, Minnesota, United States
  • University of Mississippi Medical Center — Jackson, Mississippi, United States
  • Children's Mercy Hospitals and Clinics — Kansas City, Missouri, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Children's Hospital and Medical Center of Omaha — Omaha, Nebraska, United States
  • University of Nebraska Medical Center — Omaha, Nebraska, United States
  • Hackensack University Medical Center — Hackensack, New Jersey, United States
  • Jersey Shore Medical Center — Neptune City, New Jersey, United States
  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
  • Newark Beth Israel Medical Center — Newark, New Jersey, United States
  • Albany Medical Center — Albany, New York, United States
  • Montefiore Medical Center - Moses Campus — The Bronx, New York, United States
  • Carolinas Medical Center/Levine Cancer Institute — Charlotte, North Carolina, United States
  • Duke University Medical Center — Durham, North Carolina, United States
  • East Carolina University — Greenville, North Carolina, United States
  • Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
  • Sanford Broadway Medical Center — Fargo, North Dakota, United States
  • Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
  • Rainbow Babies and Childrens Hospital — Cleveland, Ohio, United States
  • Nationwide Children's Hospital — Columbus, Ohio, United States
  • Dayton Children's Hospital — Dayton, Ohio, United States
  • University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
  • Lehigh Valley Hospital-Cedar Crest — Allentown, Pennsylvania, United States
  • Penn State Children's Hospital — Hershey, Pennsylvania, United States
  • Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
  • Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
  • Prisma Health Richland Hospital — Columbia, South Carolina, United States
  • BI-LO Charities Children's Cancer Center — Greenville, South Carolina, United States
  • Sanford USD Medical Center - Sioux Falls — Sioux Falls, South Dakota, United States
  • Saint Jude Children's Research Hospital — Memphis, Tennessee, United States
  • The Children's Hospital at TriStar Centennial — Nashville, Tennessee, United States
  • Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States
  • Dell Children's Medical Center of Central Texas — Austin, Texas, United States
  • UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas, United States
  • Cook Children's Medical Center — Fort Worth, Texas, United States
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center — Houston, Texas, United States
  • UT MD Anderson Cancer Center — Houston, Texas, United States
  • Children's Hospital of San Antonio — San Antonio, Texas, United States
  • University of Virginia Cancer Center — Charlottesville, Virginia, United States
  • Children's Hospital of The King's Daughters — Norfolk, Virginia, United States
  • VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States
  • Seattle Children's Hospital — Seattle, Washington, United States
  • Mary Bridge Children's Hospital and Health Center — Tacoma, Washington, United States
  • Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
  • John Hunter Children's Hospital — Hunter Regional Mail Centre, New South Wales, Australia
  • Alberta Children's Hospital — Calgary, Alberta, Canada
  • University of Alberta Hospital — Edmonton, Alberta, Canada
  • Hospital for Sick Children — Toronto, Ontario, Canada
  • The Montreal Children's Hospital of the MUHC — Montreal, Quebec, Canada
  • Centre Hospitalier Universitaire Sainte-Justine — Montreal, Quebec, Canada
  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont — Sherbrooke, Quebec, Canada
  • Starship Children's Hospital — Grafton, Auckland, New Zealand
  • Christchurch Hospital — Christchurch, New Zealand
  • University Pediatric Hospital — San Juan, Puerto Rico
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record