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A Study of Nivolumab and Chemotherapy for Nasopharyngeal Carcinoma

This study is testing nivolumab, an immunotherapy, combined with chemotherapy drugs (cisplatin and gemcitabine) before radiation therapy for young people with newly diagnosed nasopharyngeal carcinoma (NPC). Nivolumab works by helping your body's immune system fight cancer cells. The chemotherapy drugs aim to stop cancer cell growth and spread. This trial is looking to see how safe this combination treatment is, specifically by tracking serious immune-related side effects. It also aims to see how well the treatment shrinks tumors and how long patients live without the cancer returning. The study plans to enroll 50 participants up to 21 years old with Stage II, III, or IV NPC. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 50 participants. It is testing the combination of nivolumab with chemotherapy.
What's involved
Participants will undergo a biopsy, blood and stool sample collection, chest x-rays, and CT scans. They will receive cisplatin intravenously.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for safety is measured until the end of consolidation therapy. Other objectives include 2-year event-free survival and 5-year event-free and overall survival.

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NCT06064097

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

Recruiting
PHASE2Up to 21InterventionalTreatment
National Cancer Institute (NCI)
~50 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:Biopsy ProcedureBiospecimen CollectionChest RadiographyCisplatinComputed TomographyEchocardiography Test

At a glance

Recruiting sites
84 of 86 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of grade 3 or higher immune-related adverse events (irAE) during induction chemoimmunotherapy (CIT)
Measured over Until the end of consolidation therapy

Conditions

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

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NCT06064097

Where you'd take part

This study runs at 86 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Albany Medical Center

    Albany, New Yorkstudy coordinator listed

    Recruiting

  • Alberta Children's Hospital

    Calgary, Alberta, Canadastudy coordinator listed

    Recruiting

  • Alfred I duPont Hospital for Children

    Wilmington, Delawarestudy coordinator listed

    Recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansasstudy coordinator listed

    Recruiting

  • Arnold Palmer Hospital for Children

    Orlando, Floridastudy coordinator listed

    Recruiting

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

  • BI-LO Charities Children's Cancer Center

    Greenville, South Carolinastudy coordinator listed

    Recruiting

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolinastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Robyn D Gartrell · PRINCIPAL_INVESTIGATOR · Children's Oncology Group

Who to contact

Site Public Contact
[email protected]
205-638-9285
Email the study team

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Eligibility criteria

Inclusion

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)
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

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

What this trial measures

  • Incidence of grade 3 or higher immune-related adverse events (irAE) during induction chemoimmunotherapy (CIT)Until the end of consolidation therapy

    Will be assessed by Common Terminology Criteria for Adverse Events. IrAEs include diarrhea (noninfectious), colitis (noninfectious), pneumonitis (noninfectious), myocarditis, elevated alanine aminotransferase, elevated aspartate aminotransferase, pancreatitis, elevated blood bilirubin, hypophysitis and hyperthyroid considered possibly, probably, or definitely related to nivolumab.