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New combo aims to shrink tumors and cut radiation for young cancer patients

NCT ID NCT06064097

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 25 times

Summary

This study tests whether adding the immunotherapy drug nivolumab to standard chemotherapy (gemcitabine and cisplatin) before radiation therapy is safe and effective for children and young adults (up to age 21) with newly diagnosed nasopharyngeal carcinoma. The goal is to see if this combination can reduce the amount of radiation needed, potentially lowering long-term side effects. About 50 participants will be enrolled.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 21 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

nasopharyngeal carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stage II nasopharyngeal carcinoma ajcc V8 Stage III nasopharyngeal carcinoma ajcc V8 Stage IV nasopharyngeal carcinoma ajcc V8

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    86 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Albany Medical Center

    RECRUITING

    Albany, New York, 12208, United States

  • Alberta Children's Hospital

    RECRUITING

    Calgary, Alberta, T3B 6A8, Canada

    Contact Email: •••••@•••••

  • Alfred I duPont Hospital for Children

    RECRUITING

    Wilmington, Delaware, 19803, United States

  • Arkansas Children's Hospital

    RECRUITING

    Little Rock, Arkansas, 72202-3591, United States

  • Arnold Palmer Hospital for Children

    RECRUITING

    Orlando, Florida, 32806, United States

  • BI-LO Charities Children's Cancer Center

    RECRUITING

    Greenville, South Carolina, 29605, United States

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

    RECRUITING

    Houston, Texas, 77030, United States

  • Carolinas Medical Center/Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28203, United States

  • Centre Hospitalier Universitaire Sainte-Justine

    RECRUITING

    Montreal, Quebec, H3T 1C5, Canada

  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Children's Hospital Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

  • Children's Hospital New Orleans

    RECRUITING

    New Orleans, Louisiana, 70118, United States

  • Children's Hospital and Medical Center of Omaha

    RECRUITING

    Omaha, Nebraska, 68114, United States

  • Children's Hospital of Alabama

    RECRUITING

    Birmingham, Alabama, 35233, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Pittsburgh of UPMC

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • Children's Hospital of San Antonio

    RECRUITING

    San Antonio, Texas, 78207, United States

  • Children's Hospital of The King's Daughters

    RECRUITING

    Norfolk, Virginia, 23507, United States

    Contact Email: •••••@•••••

  • Children's Hospital of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Children's Mercy Hospitals and Clinics

    RECRUITING

    Kansas City, Missouri, 64108, United States

    Contact Email: •••••@•••••

  • Children's National Medical Center

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Christchurch Hospital

    RECRUITING

    Christchurch, 8011, New Zealand

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

    Contact Email: •••••@•••••

  • Connecticut Children's Medical Center

    RECRUITING

    Hartford, Connecticut, 06106, United States

  • Cook Children's Medical Center

    RECRUITING

    Fort Worth, Texas, 76104, United States

    Contact Email: •••••@•••••

  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Dayton Children's Hospital

    RECRUITING

    Dayton, Ohio, 45404, United States

  • Dell Children's Medical Center of Central Texas

    RECRUITING

    Austin, Texas, 78723, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • East Carolina University

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Hospital for Sick Children

    RECRUITING

    Toronto, Ontario, M5G 1X8, Canada

  • Jersey Shore Medical Center

    RECRUITING

    Neptune City, New Jersey, 07753, United States

  • John Hunter Children's Hospital

    RECRUITING

    Hunter Regional Mail Centre, New South Wales, 2310, Australia

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Kaiser Permanente Downey Medical Center

    RECRUITING

    Downey, California, 90242, United States

  • Kaiser Permanente-Oakland

    RECRUITING

    Oakland, California, 94611, United States

  • Lehigh Valley Hospital-Cedar Crest

    RECRUITING

    Allentown, Pennsylvania, 18103, United States

  • Loma Linda University Medical Center

    RECRUITING

    Loma Linda, California, 92354, United States

  • Lurie Children's Hospital-Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Maine Children's Cancer Program

    RECRUITING

    Scarborough, Maine, 04074, United States

    Contact Email: •••••@•••••

  • Mary Bridge Children's Hospital and Health Center

    RECRUITING

    Tacoma, Washington, 98405, United States

    Contact Email: •••••@•••••

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Montefiore Medical Center - Moses Campus

    RECRUITING

    The Bronx, New York, 10467, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Nemours Children's Clinic - Pensacola

    RECRUITING

    Pensacola, Florida, 32504, United States

    Contact Email: •••••@•••••

  • Nemours Children's Clinic-Jacksonville

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Nemours Children's Hospital

    RECRUITING

    Orlando, Florida, 32827, United States

  • Newark Beth Israel Medical Center

    RECRUITING

    Newark, New Jersey, 07112, United States

  • Nicklaus Children's Hospital

    RECRUITING

    Miami, Florida, 33155, United States

  • Penn State Children's Hospital

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Phoenix Childrens Hospital

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Prisma Health Richland Hospital

    RECRUITING

    Columbia, South Carolina, 29203, United States

  • Rady Children's Hospital - San Diego

    RECRUITING

    San Diego, California, 92123, United States

  • Rainbow Babies and Childrens Hospital

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Riley Hospital for Children

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • Saint Joseph's Hospital/Children's Hospital-Tampa

    RECRUITING

    Tampa, Florida, 33607, United States

  • Saint Jude Children's Research Hospital

    RECRUITING

    Memphis, Tennessee, 38105, United States

    Contact Email: •••••@•••••

  • Sanford Broadway Medical Center

    RECRUITING

    Fargo, North Dakota, 58122, United States

    Contact Email: •••••@•••••

  • Sanford USD Medical Center - Sioux Falls

    RECRUITING

    Sioux Falls, South Dakota, 57117-5134, United States

    Contact Email: •••••@•••••

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

  • Starship Children's Hospital

    RECRUITING

    Grafton, Auckland, 1145, New Zealand

  • The Children's Hospital at TriStar Centennial

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • The Montreal Children's Hospital of the MUHC

    RECRUITING

    Montreal, Quebec, H3H 1P3, Canada

    Contact Email: •••••@•••••

  • UCSF Benioff Children's Hospital Oakland

    RECRUITING

    Oakland, California, 94609, United States

  • UCSF Medical Center-Mission Bay

    RECRUITING

    San Francisco, California, 94158, United States

    Contact Email: •••••@•••••

  • UF Health Cancer Institute - Gainesville

    RECRUITING

    Gainesville, Florida, 32610, United States

    Contact Email: •••••@•••••

  • UT MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • UT Southwestern/Simmons Cancer Center-Dallas

    RECRUITING

    Dallas, Texas, 75390, United States

    Contact Email: •••••@•••••

  • University Pediatric Hospital

    RECRUITING

    San Juan, 00926, Puerto Rico

  • University of Alberta Hospital

    RECRUITING

    Edmonton, Alberta, T6G 2B7, Canada

    Contact Email: •••••@•••••

  • University of Chicago Comprehensive Cancer Center

    SUSPENDED

    Chicago, Illinois, 60637, United States

  • University of Kentucky/Markey Cancer Center

    NOT_YET_RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Mississippi Medical Center

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Virginia Cancer Center

    RECRUITING

    Charlottesville, Virginia, 22908, United States

    Contact Email: •••••@•••••

  • VCU Massey Comprehensive Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, United States

  • Valley Children's Hospital

    RECRUITING

    Madera, California, 93636, United States

    Contact Email: •••••@•••••

  • Vanderbilt University/Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

    Contact Email: •••••@•••••

More trials for these conditions

Other studies related to the condition(s) this trial covers.