Clinical trial Recruiting at 84 sites Phase 2 Interventional Ages Any age to 21

Using nivolumab with chemotherapy to treat nasopharyngeal carcinoma in young patients

Official title: A Phase 2 Study Using Chemoimmunotherapy With Gemcitabine, Cisplatin and Nivolumab in Newly Diagnosed Nasopharyngeal Carcinoma (NPC)

Run by National Cancer Institute (NCI) · NCT06064097 · Data updated 2026-11-12

This study is testing if combining nivolumab with chemotherapy can help young patients with nasopharyngeal carcinoma live longer and feel better while reducing side effects from radiation.

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Quick facts

PhasePhase 2
Study typeInterventional
AgesAny age to 21 Years
SexAll
Enrollment50 (estimated)
SponsorNational Cancer Institute (NCI)
NIH
Drugs / interventionsnivolumab, chemotherapy, radiation, prednisone, Immunotherapy
Locations86 sites (Birmingham, Alabama and 85 other locations)
StatusRecruiting
StartedJune 25, 2024
Main results expectedMarch 31, 2027
Study endsMarch 31, 2027
Registry record updatedOctober 14, 2026
Trial IDNCT06064097 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients aged 21 years or younger with newly diagnosed stage II-IV nasopharyngeal carcinoma.

Probably not a fit

Patients with other types of cancer or those older than 21 years may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial evaluates the safety and efficacy of combining nivolumab, an immune checkpoint inhibitor, with chemotherapy drugs cisplatin and gemcitabine in children, adolescents, and young adults diagnosed with nasopharyngeal carcinoma (NPC). The study aims to assess the rate of serious immune-related adverse events and the overall effectiveness of this combination therapy in improving event-free survival rates. Participants will receive induction chemoimmunotherapy followed by consolidation chemoradioimmunotherapy and nivolumab maintenance therapy, with a focus on reducing radiation exposure in younger patients to minimize side effects. The trial also includes exploratory objectives to evaluate long-term survival outcomes and response rates using advanced imaging techniques.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and reduce side effects for young patients with nasopharyngeal carcinoma.

How similar studies have gone: Other studies have shown promise in using immunotherapy in combination with chemotherapy for various cancers, suggesting potential success for this approach in NPC.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Children's Hospital of Alabama
    Birmingham, Alabama, United States
    Recruiting
  • Phoenix Childrens Hospital
    Phoenix, Arizona, United States
    Recruiting
  • Arkansas Children's Hospital
    Little Rock, Arkansas, United States
    Recruiting
  • Kaiser Permanente Downey Medical Center
    Downey, California, United States
    Recruiting
  • Loma Linda University Medical Center
    Loma Linda, California, United States
    Recruiting
  • Children's Hospital Los Angeles
    Los Angeles, California, United States
    Recruiting
Show 44 more locations
  • Valley Children's Hospital
    Madera, California, United States
    Recruiting
  • UCSF Benioff Children's Hospital Oakland
    Oakland, California, United States
    Recruiting
  • Kaiser Permanente-Oakland
    Oakland, California, United States
    Recruiting
  • Rady Children's Hospital - San Diego
    San Diego, California, United States
    Recruiting
  • UCSF Medical Center-Mission Bay
    San Francisco, California, United States
    Recruiting
  • Children's Hospital Colorado
    Aurora, Colorado, United States
    Recruiting
  • Connecticut Children's Medical Center
    Hartford, Connecticut, United States
    Recruiting
  • Alfred I duPont Hospital for Children
    Wilmington, Delaware, United States
    Recruiting
  • Children's National Medical Center
    Washington D.C., District of Columbia, United States
    Recruiting
  • UF Health Cancer Institute - Gainesville
    Gainesville, Florida, United States
    Recruiting
  • Nemours Children's Clinic-Jacksonville
    Jacksonville, Florida, United States
    Recruiting
  • Nicklaus Children's Hospital
    Miami, Florida, United States
    Recruiting
  • Arnold Palmer Hospital for Children
    Orlando, Florida, United States
    Recruiting
  • Nemours Children's Hospital
    Orlando, Florida, United States
    Recruiting
  • Nemours Children's Clinic - Pensacola
    Pensacola, Florida, United States
    Recruiting
  • Saint Joseph's Hospital/Children's Hospital-Tampa
    Tampa, Florida, United States
    Recruiting
  • Children's Healthcare of Atlanta - Arthur M Blank Hospital
    Atlanta, Georgia, United States
    Recruiting
  • Lurie Children's Hospital-Chicago
    Chicago, Illinois, United States
    Recruiting
  • Riley Hospital for Children
    Indianapolis, Indiana, United States
    Recruiting
  • Children's Hospital New Orleans
    New Orleans, Louisiana, United States
    Recruiting
  • Maine Children's Cancer Program
    Scarborough, Maine, United States
    Recruiting
  • Johns Hopkins University/Sidney Kimmel Cancer Center
    Baltimore, Maryland, United States
    Recruiting
  • Dana-Farber Cancer Institute
    Boston, Massachusetts, United States
    Recruiting
  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
    Grand Rapids, Michigan, United States
    Recruiting
  • Mayo Clinic in Rochester
    Rochester, Minnesota, United States
    Recruiting
  • University of Mississippi Medical Center
    Jackson, Mississippi, United States
    Recruiting
  • Children's Mercy Hospitals and Clinics
    Kansas City, Missouri, United States
    Recruiting
  • Washington University School of Medicine
    St Louis, Missouri, United States
    Recruiting
  • Children's Hospital and Medical Center of Omaha
    Omaha, Nebraska, United States
    Recruiting
  • University of Nebraska Medical Center
    Omaha, Nebraska, United States
    Recruiting
  • Hackensack University Medical Center
    Hackensack, New Jersey, United States
    Recruiting
  • Jersey Shore Medical Center
    Neptune City, New Jersey, United States
    Recruiting
  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
    New Brunswick, New Jersey, United States
    Recruiting
  • Newark Beth Israel Medical Center
    Newark, New Jersey, United States
    Recruiting
  • Albany Medical Center
    Albany, New York, United States
    Recruiting
  • Montefiore Medical Center - Moses Campus
    The Bronx, New York, United States
    Recruiting
  • Carolinas Medical Center/Levine Cancer Institute
    Charlotte, North Carolina, United States
    Recruiting
  • Duke University Medical Center
    Durham, North Carolina, United States
    Recruiting
  • East Carolina University
    Greenville, North Carolina, United States
    Recruiting
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina, United States
    Recruiting
  • Sanford Broadway Medical Center
    Fargo, North Dakota, United States
    Recruiting
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio, United States
    Recruiting
  • Rainbow Babies and Childrens Hospital
    Cleveland, Ohio, United States
    Recruiting
  • Nationwide Children's Hospital
    Columbus, Ohio, United States
    Recruiting

+36 more sites. See ClinicalTrials.gov for the full list.

Study contacts

  • Principal investigator: Robyn D Gartrell — Children's Oncology Group

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.