AzTrials
AzTrials

Stage II Nasopharyngeal Carcinoma AJCC v8Phase 2NCT06064097

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

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Chest Radiography in people with Stage II Nasopharyngeal Carcinoma AJCC v8 and Stage III Nasopharyngeal Carcinoma AJCC v8, run by National Cancer Institute (NCI) at 86 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages Up to 21 years
What is being tested?
Biopsy Procedure, Biospecimen Collection and Chest Radiography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
86 sitesin 5 countries
Study dates
25 Jun 2024to 31 Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 22Show fewer
  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

86 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

86 sites in 5 countries

United States76 sites, 75 recruiting

  • Albany Medical Center

    Albany, New York, 12208

    Site Public Contact, 518-262-5513

    Lauren R. Weintraub

    Recruiting

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

    Site Public Contact, 610-402-9543, Morgan_M.Horton@lvhn.org

    Jacob A. Troutman

    Recruiting

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

    Atlanta, Georgia, 30329

    Site Public Contact, 404-785-0232, Olivia.Floyd@choa.org

    Sarah G. Mitchell

    Recruiting

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

    Site Public Contact, 303-764-5056, josh.b.gordon@nsmtp.kp.org

    Navin R. Pinto

    Recruiting

  • Dell Children's Medical Center of Central Texas

    Austin, Texas, 78723

    Site Public Contact, 512-628-1902, TXAUS-DL-SFCHemonc.research@ascension.org

    Shannon M. Cohn

    Recruiting

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287

    Site Public Contact, 410-955-8804, jhcccro@jhmi.edu

    Robyn D. Gartrell

    Recruiting

  • Children's Hospital of Alabama

    Birmingham, Alabama, 35233

    Site Public Contact, 205-638-9285, oncologyresearch@peds.uab.edu

    Jamie M. Aye

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Site Public Contact, 877-442-3324

    Allison F. O'Neill

    Recruiting

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

    Site Public Contact, 800-804-9376

    Joel A. Kaplan

    Recruiting

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

    Site Public Contact, 434-243-6303, uvacancertrials@hscmail.mcc.virginia.edu

    Brian C. Belyea

    Recruiting

  • Lurie Children's Hospital-Chicago

    Chicago, Illinois, 60611

    Site Public Contact, 773-880-4562

    Amy L. Walz

    Recruiting

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

    Suspended

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

    Site Public Contact, 513-636-2799, cancer@cchmc.org

    Brian K. Turpin

    Recruiting

  • Rainbow Babies and Childrens Hospital

    Cleveland, Ohio, 44106

    Site Public Contact, 216-844-5437

    Duncan S. Stearns

    Recruiting

  • Prisma Health Richland Hospital

    Columbia, South Carolina, 29203

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Stuart L. Cramer

    Recruiting

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

    Site Public Contact, 614-722-6039, Melinda.Triplet@nationwidechildrens.org

    Mark A. Ranalli

    Recruiting

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    Avanthi T. Shah

    Recruiting

  • Dayton Children's Hospital

    Dayton, Ohio, 45404

    Site Public Contact, 800-228-4055

    Jordan M. Wright

    Recruiting

  • Kaiser Permanente Downey Medical Center

    Downey, California, 90242

    Site Public Contact, 626-564-3455

    Robert M. Cooper

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Site Public Contact, 888-275-3853

    Jessica M. Sun

    Recruiting

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Samuel J. Milanovich

    Recruiting

  • Cook Children's Medical Center

    Fort Worth, Texas, 76104

    Site Public Contact, 682-885-2103, CookChildrensResearch@cookchildrens.org

    Chelsee Greer

    Recruiting

  • UF Health Cancer Institute - Gainesville

    Gainesville, Florida, 32610

    Site Public Contact, 352-273-8010, cancer-center@ufl.edu

    Brian Stover

    Recruiting

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

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • East Carolina University

    Greenville, North Carolina, 27834

    Site Public Contact, 252-744-1015, eubankss@ecu.edu

    Andrea R. Whitfield

    Recruiting

  • BI-LO Charities Children's Cancer Center

    Greenville, South Carolina, 29605

    Site Public Contact, 864-522-4317, Kim.Williams3@prismahealth.org

    Aniket Saha

    Recruiting

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

    Site Public Contact, 551-996-2897

    Katharine Offer

    Recruiting

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

    Site Public Contact, 860-545-9981

    Michael S. Isakoff

    Recruiting

  • Penn State Children's Hospital

    Hershey, Pennsylvania, 17033

    Site Public Contact, 717-531-6012

    Lisa M. McGregor

    Recruiting

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

    Houston, Texas, 77030

    Site Public Contact, 713-798-1354, burton@bcm.edu

    Mehmet F. Okcu

    Recruiting

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

    Site Public Contact, 866-632-6789, askmdanderson@mdanderson.org

    Najat C. Daw

    Recruiting

  • Riley Hospital for Children

    Indianapolis, Indiana, 46202

    Site Public Contact, 800-248-1199

    Marissa Just

    Recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Site Public Contact, 601-815-6700

    Amanda Strobel

    Recruiting

  • Nemours Children's Clinic-Jacksonville

    Jacksonville, Florida, 32207

    Site Public Contact, 302-651-5572, Allison.bruce@nemours.org

    Sridhi Patel

    Recruiting

  • Children's Mercy Hospitals and Clinics

    Kansas City, Missouri, 64108

    Site Public Contact, 816-302-6808, COGResearchGroup@cmh.edu

    Keith J. August

    Recruiting

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

    Site Public Contact, 859-257-3379

    James T. Badgett

    Not yet recruiting

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202-3591

    Site Public Contact, 501-364-7373

    Michael W. Bishop

    Recruiting

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

    Site Public Contact, 909-558-4050

    Albert Kheradpour

    Recruiting

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

    Site Public Contact, 323-361-4110

    Rachana Shah

    Recruiting

  • Valley Children's Hospital

    Madera, California, 93636

    Site Public Contact, 559-353-3000, Research@valleychildrens.org

    Ruetima Titapiwatanakun

    Recruiting

  • Saint Jude Children's Research Hospital

    Memphis, Tennessee, 38105

    Site Public Contact, 888-226-4343, referralinfo@stjude.org

    Catherine G. Lam

    Recruiting

  • Nicklaus Children's Hospital

    Miami, Florida, 33155

    Site Public Contact, 888-624-2778

    Ziad A. Khatib

    Recruiting

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53226

    Site Public Contact, 414-955-4727, MACCCTO@mcw.edu

    Angela Steineck

    Recruiting

  • The Children's Hospital at TriStar Centennial

    Nashville, Tennessee, 37203

    Site Public Contact, 615-342-1919

    Clinton M. Carroll

    Recruiting

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

    Site Public Contact, 800-811-8480

    Scott C. Borinstein

    Recruiting

  • Jersey Shore Medical Center

    Neptune City, New Jersey, 07753

    Site Public Contact, 732-776-4240

    Katharine Offer

    Recruiting

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

    New Brunswick, New Jersey, 08903

    Site Public Contact, 732-235-8675

    Scott Moerdler

    Recruiting

  • Children's Hospital New Orleans

    New Orleans, Louisiana, 70118

    Site Public Contact, 504-894-5377

    Maria C. Velez-Yanguas

    Recruiting

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

    Site Public Contact, 973-926-7230, Christine.Kosmides@rwjbh.org

    Teena Bhatla

    Recruiting

  • Children's Hospital of The King's Daughters

    Norfolk, Virginia, 23507

    Site Public Contact, 757-668-7243, CCBDCresearch@chkd.org

    Melissa S. Mark

    Recruiting

  • UCSF Benioff Children's Hospital Oakland

    Oakland, California, 94609

    Site Public Contact, 510-428-3264, PedOncRschOAK@ucsf.edu

    Jennifer G. Michlitsch

    Recruiting

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Aarati V. Rao

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Rene Y. McNall-Knapp

    Recruiting

  • Children's Hospital and Medical Center of Omaha

    Omaha, Nebraska, 68114

    Site Public Contact, 402-955-3949

    Jill C. Beck

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Site Public Contact, 402-559-6941, unmcrsa@unmc.edu

    Jill C. Beck

    Recruiting

  • Arnold Palmer Hospital for Children

    Orlando, Florida, 32806

    Site Public Contact, 321-841-5357, Jennifer.spinelli@orlandohealth.com

    Zhongbo Hu

    Recruiting

  • Nemours Children's Hospital

    Orlando, Florida, 32827

    Site Public Contact, 302-651-5572, Allison.bruce@nemours.org

    Sridhi Patel

    Recruiting

  • Nemours Children's Clinic - Pensacola

    Pensacola, Florida, 32504

    Site Public Contact, helpdesk@childrensoncologygroup.org

    Jeffrey H. Schwartz

    Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Site Public Contact, 267-425-5544, CancerTrials@email.chop.edu

    Theodore W. Laetsch

    Recruiting

  • Phoenix Childrens Hospital

    Phoenix, Arizona, 85016

    Site Public Contact, 602-546-0920

    Alok K. Kothari

    Recruiting

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224

    Site Public Contact, 412-692-8570, jean.tersak@chp.edu

    Brittani K. Seynnaeve

    Recruiting

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

    Site Public Contact, 804-628-6430, CTOclinops@vcu.edu

    Madhu S. Gowda

    Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Site Public Contact, 855-776-0015

    Peter Schoettler

    Recruiting

  • Children's Hospital of San Antonio

    San Antonio, Texas, 78207

    Site Public Contact, 210-704-2894, bridget.medina@christushealth.org

    Julie Voeller

    Recruiting

  • Rady Children's Hospital - San Diego

    San Diego, California, 92123

    Site Public Contact, 858-966-5934

    William D. Roberts

    Recruiting

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158

    Site Public Contact, 877-827-3222, cancertrials@ucsf.edu

    Arun A. Rangaswami

    Recruiting

  • Maine Children's Cancer Program

    Scarborough, Maine, 04074

    Site Public Contact, 207-396-8670, clinicalresearch@mainehealth.org

    Aaron R. Weiss

    Recruiting

  • Seattle Children's Hospital

    Seattle, Washington, 98105

    Site Public Contact, 866-987-2000

    Sarah E. Leary

    Recruiting

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

    Site Public Contact, 605-312-3320, OncologyClinicalTrialsSF@SanfordHealth.org

    Jordan Fritch-Hanson

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Frederick S. Huang

    Recruiting

  • Mary Bridge Children's Hospital and Health Center

    Tacoma, Washington, 98405

    Site Public Contact, 253-403-1461, research@multicare.org

    Robert G. Irwin

    Recruiting

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

    Tampa, Florida, 33607

    Site Public Contact, 813-357-0849, jennifer.manns@baycare.org

    Don E. Eslin

    Recruiting

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

    Site Public Contact, 718-379-6866, eskwak@montefiore.org

    Alice Lee

    Recruiting

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

    Site Public Contact, 202-476-2800, OncCRC_OnCall@childrensnational.org

    Jeffrey S. Dome

    Recruiting

  • Alfred I duPont Hospital for Children

    Wilmington, Delaware, 19803

    Site Public Contact, 302-651-5572, Allison.bruce@nemours.org

    Sridhi Patel

    Recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

    Site Public Contact, 336-713-6771

    Sarah Supples

    Recruiting

Other trials in United States

Canada6 sites, 6 recruiting

  • Alberta Children's Hospital

    Calgary, Alberta, T3B 6A8

    Site Public Contact, 403-220-6898, research4kids@ucalgary.ca

    Victor A. Lewis

    Recruiting

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

    Site Public Contact, 780-407-8798, pedsoncologyresearch@ahs.ca

    Sarah J. McKillop

    Recruiting

  • The Montreal Children's Hospital of the MUHC

    Montreal, Quebec, H3H 1P3

    Site Public Contact, 514-412-4445, info@thechildren.com

    Stephanie Mourad

    Recruiting

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec, H3T 1C5

    Site Public Contact, 514-345-4931, yvan.samson@umontreal.ca

    Monia Marzouki

    Recruiting

  • Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

    Sherbrooke, Quebec, J1H 5N4

    Site Public Contact, 819-820-6480, crcinformation.chus@ssss.gouv.qc.ca

    Stephanie Vairy

    Recruiting

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

    Site Public Contact, 416-813-7654, ask.CRS@sickkids.ca

    Avram E. Denburg

    Recruiting

Other trials in Canada

New Zealand2 sites, 2 recruiting

  • Christchurch Hospital

    Christchurch, 8011

    Site Public Contact, 03 364 0640

    Tristan Pettit

    Recruiting

  • Starship Children's Hospital

    Grafton, Auckland, 1145

    Site Public Contact, 0800 728 436

    Leander D. Timothy

    Recruiting

Other trials in New Zealand

Australia1 site, 1 recruiting

  • John Hunter Children's Hospital

    Hunter Regional Mail Centre, New South Wales, 2310

    Site Public Contact, (02) 4985 5180

    Kristy McCarthy

    Recruiting

Other trials in Australia

Puerto Rico1 site, 1 recruiting

  • University Pediatric Hospital

    San Juan, 00926

    Site Public Contact, 787-474-0333

    Maria E. Echevarria

    Recruiting

Other trials in Puerto Rico

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate safety of combining chemotherapy (cisplatin and gemcitabine) with an anti-PD1 immune checkpoint inhibitor (nivolumab) in children, adolescents and young adults with nasopharyngeal carcinoma (NPC) by determining the rate of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher immune related adverse events (irAEs).

SECONDARY OBJECTIVES:

  1. To estimate the 2-year event-free survival (EFS) of children, adolescents and young adults with NPC who are treated with induction chemoimmunotherapy (CIT), followed by consolidation chemoradioimmunotherapy (CRIT, cisplatin, nivolumab and response-adjusted, dose de-escalated radiation therapy), and nivolumab maintenance therapy.

II. To evaluate the objective response rate (ORR) including complete responders and partial responders (complete response [CR] + partial response [PR]) of neoadjuvant CIT.

III. To evaluate feasibility of combining chemotherapy (cisplatin and gemcitabine) with an anti-PD1 immune checkpoint inhibitor (nivolumab) in children, adolescents and young adults with nasopharyngeal carcinoma (NPC).

IV. To evaluate the cumulative incidence of local and distant relapse.

EXPLORATORY OBJECTIVES:

  1. To estimate 5-year EFS and overall survival (OS) of children with NPC who are treated with induction CIT followed by consolidation CRIT, and nivolumab maintenance therapy.

II. To compare response assessed by fludeoxyglucose F18 (FDG) positron emission tomography (PET) versus magnetic resonance imaging (MRI).

III. To determine treatment outcomes for patients treated with radiation per protocol versus (vs) deviation.

IV. To evaluate outcomes comparing patients receiving intensity modulated radiation therapy (IMRT) to proton therapy.

  1. To objectively measure both acute and long-term toxicity including immune related adverse events and radiation late effects.

VI. To evaluate swallowing dysfunction using patient reported outcome (PRO) measures for children and adults throughout the protocol for up to 5 years.

VII. To evaluate quality of life (QOL) using Patient-Reported Outcomes Measurement Information System (PROMIS) multidimensional questionnaire throughout the protocol for up to 5 years.

VIII. To correlate the lymphocyte to monocyte ratio on complete blood counts (CBCs) with treatment response and outcomes.

IX. To collect and bank specimens (including tumor, blood and stool) for future research studies.

OUTLINE:

INDUCTION THERAPY: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 of each cycle, gemcitabine IV over 30 minutes on days 1 and 8 of each cycle, and cisplatin IV over 3-6 hours on day 1 of each cycle. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION THERAPY: Patients receive nivolumab IV over 30 minutes on day 1 of each cycle and cisplatin IV over 3-6 hours on day 1 of cycles 1-2. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive concurrent radiation therapy on trial.

MAINTENANCE THERAPY: Patients receive nivolumab IV over 30 minutes on day 1 of each cycle. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

Patients also undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening and as clinically indicated on trial. Patients undergo MRI, FDG PET, and computed tomography (CT) throughout the trial and chest x-ray during follow-up. Patients also undergo dental x-ray imaging on the trial. Patients may optionally undergo tissue biopsy, blood and stool sample collection during screening and on trial.

After completion of study treatment, patients are followed up every 3 months for 12 months, every 6 months until 24 months off therapy, and then yearly until 5 years off therapy.

Being tested
Biopsy Procedure, Biospecimen Collection, Chest Radiography, Cisplatin, Computed Tomography
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo tissue biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood and stool sample collection

  • Chest RadiographyProcedure or surgery

    Also called Chest X-ray

    Undergo chest x-ray

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Echocardiography TestProcedure or surgery

    Also called EC, Echocardiography

    Undergo ECHO

  • Electronic Health Record ReviewOther

    Ancillary studies

  • Fluciclovine F18Other

    Also called (18F)Fluciclovine, (18F)GE-148, 18F-Fluciclovine, [18F]FACBC

    Given IV

  • GemcitabineDrug

    Also called dFdC, dFdCyd, Difluorodeoxycytidine

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Multigated Acquisition ScanProcedure or surgery

    Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan

    Undergo MUGA

  • NivolumabBiological

    Also called ABP 206, BCD-263, BMS 936558, BMS-936558

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate

    Receive radiation therapy

  • X-Ray ImagingProcedure or surgery

    Also called Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Plain film radiographs

    Undergo dental x-ray

Study groups in NCT06064097
Study groupRoleWhat they receive
Treatment (nivolumab, gemcitabine, cisplatin, radiation)ExperimentalSee Detailed Description
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Chest Radiography; Drug: Cisplatin; Procedure: Computed Tomography; Procedure: Echocardiography Test; Other: Electronic Health Record Review; Other: Fluciclovine F18; Drug: Gemcitabine; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan; Biological: Nivolumab; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Therapy; Procedure: X-Ray Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of grade 3 or higher immune-related adverse events (irAE) during induction chemoimmunotherapy (CIT)

    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.

    Measured: Until the end of consolidation therapy

Secondary outcomes (4)

  1. Event-free survival (EFS)

    EFS along with the 95% confidence intervals will be estimated using the Kaplan-Meier method. The EFS will be reported separately for patients with non-metastatic disease and those with metastatic disease (if there are enough patients with metastatic disease enrolled).

    Measured: From date of enrollment to the earliest occurrence of date of relapse, disease progression, second malignant neoplasm or death due to any cause, assessed at 2 years

  2. Objective response rate

    Will be defined as the rate of responders among evaluable patients using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measured: At the end of induction CIT

  3. Feasibility success of the induction regimen

    Will be defined as the completion of three cycles of induction without delay of greater than 30 days for radiation initiation due to toxicity in 80% of patients.

    Measured: At the end of induction CIT

  4. Cumulative incidence of local or distant relapse

    Defined as a function of time since enrollment will be estimated by the method of Gray.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2023
  2. Study start25 Jun 2024
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06064097
Sponsor's protocol ID
NCI-2023-07208
Other IDs
NCI-2023-07208, ARAR2221, ARAR2221, U10CA180886
Status last verified
Aug 2026
First submitted
29 Sep 2023
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biopsy Procedure, Biospecimen Collection and Chest Radiography in people with Stage II Nasopharyngeal Carcinoma AJCC v8 and Stage III Nasopharyngeal Carcinoma AJCC v8, run by National Cancer Institute (NCI) at 86 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, Canada, New Zealand, Australia, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of grade 3 or higher immune-related adverse events (irAE) during induction chemoimmunotherapy (CIT) (time frame: Until the end of consolidation therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06064097.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in