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Clinical Trials in Australia / NCT06064097
Recruiting Phase 2

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

NCT06064097 · tracked via the Priya Life Science Australia tracker
Phase
Phase 2
Started
2024-06-25
Last updated
2026-09-14

Condition(s) studied

Stage II Nasopharyngeal Carcinoma AJCC v8Stage III Nasopharyngeal Carcinoma AJCC v8Stage IV Nasopharyngeal Carcinoma AJCC v8

Investigational drug(s) / intervention(s)

Biopsy ProcedureBiospecimen CollectionChest RadiographyCisplatin →Computed TomographyEchocardiography TestElectronic Health Record ReviewFluciclovine F18Gemcitabine →Magnetic Resonance ImagingMultigated Acquisition ScanNivolumab →Positron Emission TomographyQuality-of-Life AssessmentQuestionnaire AdministrationRadiation TherapyX-Ray Imaging

Biopsy Procedure: Undergo tissue biopsy

Biospecimen Collection: Undergo blood and stool sample collection

Chest Radiography: Undergo chest x-ray

Cisplatin: Given IV

Computed Tomography: Undergo CT

Echocardiography Test: Undergo ECHO

Electronic Health Record Review: Ancillary studies

Fluciclovine F18: Given IV

Gemcitabine: Given IV

Magnetic Resonance Imaging: Undergo MRI

Multigated Acquisition Scan: Undergo MUGA

Nivolumab: Given IV

Positron Emission Tomography: Undergo PET

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Radiation Therapy: Receive radiation therapy

X-Ray Imaging: Undergo dental x-ray

Study 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 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.

Eligibility

Sex
ALL
Min age
—
Max age
21 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (86)

FacilityCityRegionStatus
Children's Hospital of Alabama Birmingham Alabama Recruiting
Phoenix Childrens Hospital Phoenix Arizona Recruiting
Arkansas Children's Hospital Little Rock Arkansas Recruiting
Kaiser Permanente Downey Medical Center Downey California Recruiting
Loma Linda University Medical Center Loma Linda California Recruiting
Children's Hospital Los Angeles Los Angeles California Recruiting
Valley Children's Hospital Madera California Recruiting
UCSF Benioff Children's Hospital Oakland Oakland California Recruiting
Kaiser Permanente-Oakland Oakland California Recruiting
Rady Children's Hospital - San Diego San Diego California Recruiting
UCSF Medical Center-Mission Bay San Francisco California Recruiting
Children's Hospital Colorado Aurora Colorado Recruiting
Connecticut Children's Medical Center Hartford Connecticut Recruiting
Alfred I duPont Hospital for Children Wilmington Delaware Recruiting
Children's National Medical Center Washington D.C. District of Columbia Recruiting
UF Health Cancer Institute - Gainesville Gainesville Florida Recruiting
Nemours Children's Clinic-Jacksonville Jacksonville Florida Recruiting
Nicklaus Children's Hospital Miami Florida Recruiting
Arnold Palmer Hospital for Children Orlando Florida Recruiting
Nemours Children's Hospital Orlando Florida Recruiting
Nemours Children's Clinic - Pensacola Pensacola Florida Recruiting
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida Recruiting
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta Georgia Recruiting
Lurie Children's Hospital-Chicago Chicago Illinois Recruiting
University of Chicago Comprehensive Cancer Center Chicago Illinois Suspended
Riley Hospital for Children Indianapolis Indiana Recruiting
University of Kentucky/Markey Cancer Center Lexington Kentucky Not Yet Recruiting
Children's Hospital New Orleans New Orleans Louisiana Recruiting
Maine Children's Cancer Program Scarborough Maine Recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland Recruiting
Dana-Farber Cancer Institute Boston Massachusetts Recruiting
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids Michigan Recruiting
Mayo Clinic in Rochester Rochester Minnesota Recruiting
University of Mississippi Medical Center Jackson Mississippi Recruiting
Children's Mercy Hospitals and Clinics Kansas City Missouri Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Children's Hospital and Medical Center of Omaha Omaha Nebraska Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
Hackensack University Medical Center Hackensack New Jersey Recruiting
Jersey Shore Medical Center Neptune City New Jersey Recruiting

+ 46 more sites — see the full list on the official registry below.

On this site

📄 Opdivo (nivolumab) drug profile →

More National Cancer Institute (NCI) trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06064097 on ClinicalTrials.gov ↗ ← All trials in Australia