RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-06-25

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06064097

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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/gender (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	* 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

Inclusion Criteria

Exclusion 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/gender (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

* 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

Contacts and Locations

Principal Investigator

Robyn D Gartrell

PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Study Locations (Sites)

Children's Hospital of Alabama

Birmingham, Alabama, 35233

United States

Arkansas Children's Hospital

Little Rock, Arkansas, 72202-3591

United States

Kaiser Permanente Downey Medical Center

Downey, California, 90242

United States

Loma Linda University Medical Center

Loma Linda, California, 92354

United States

Valley Children's Hospital

Madera, California, 93636

United States

UCSF Benioff Children's Hospital Oakland

Oakland, California, 94609

United States

Kaiser Permanente-Oakland

Oakland, California, 94611

United States

Rady Children's Hospital - San Diego

San Diego, California, 92123

United States

UCSF Medical Center-Mission Bay

San Francisco, California, 94158

United States

Children's Hospital Colorado

Aurora, Colorado, 80045

United States

Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803

United States

Children's National Medical Center

Washington, District of Columbia, 20010

United States

University of Florida Health Science Center - Gainesville

Gainesville, Florida, 32610

United States

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, 32207

United States

Nicklaus Children's Hospital

Miami, Florida, 33155

United States

Arnold Palmer Hospital for Children

Orlando, Florida, 32806

United States

Nemours Children's Hospital

Orlando, Florida, 32827

United States

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

Tampa, Florida, 33607

United States

Lurie Children's Hospital-Chicago

Chicago, Illinois, 60611

United States

Riley Hospital for Children

Indianapolis, Indiana, 46202

United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287

United States

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

Grand Rapids, Michigan, 49503

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

University of Mississippi Medical Center

Jackson, Mississippi, 39216

United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, 68114

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

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

New Brunswick, New Jersey, 08903

United States

Newark Beth Israel Medical Center

Newark, New Jersey, 07112

United States

Albany Medical Center

Albany, New York, 12208

United States

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

United States

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, 44106

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224

United States

Prisma Health Richland Hospital

Columbia, South Carolina, 29203

United States

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105

United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232

United States

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723

United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390

United States

Cook Children's Medical Center

Fort Worth, Texas, 76104

United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, 77030

United States

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Children's Hospital of San Antonio

San Antonio, Texas, 78207

United States

University of Virginia Cancer Center

Charlottesville, Virginia, 22908

United States

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507

United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

United States

Seattle Children's Hospital

Seattle, Washington, 98105

United States

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, 98405

United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

Robyn D Gartrell, PRINCIPAL_INVESTIGATOR, Children's Oncology Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-25

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-06-25

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

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