Actively Recruiting
A Phase 2 Study Using Chemoimmunotherapy With Gemcitabine, Cisplatin and Nivolumab in Newly Diagnosed Nasopharyngeal Carcinoma (NPC)
Led by National Cancer Institute (NCI) · Updated on 2026-06-03
50
Participants Needed
85
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of adding nivolumab, an immune checkpoint inhibitor, to chemotherapy drugs gemcitabine and cisplatin before radiation therapy in children, adolescents, and young adults newly diagnosed with nasopharyngeal carcinoma (NPC). The study focuses on understanding how this combination affects tumor growth and spread, while also assessing the potential to reduce radiation therapy doses and side effects in younger patients. The treatment plan includes three phases: induction therapy with nivolumab, gemcitabine, and cisplatin given intravenously in 3 cycles every 21 days; consolidation therapy with nivolumab and cisplatin alongside radiation therapy for 3 cycles every 21 days; and maintenance therapy with nivolumab every 28 days for 6 cycles. Patients receive various imaging scans such as MRI, FDG PET, CT, chest x-rays, and dental x-rays, as well as optional biopsies and sample collections to monitor response and safety. Participants will be closely monitored through regular cardiac tests, imaging, and laboratory assessments throughout treatment and follow-up. Follow-up visits occur every 3 months for the first year, every 6 months until 2 years off therapy, and annually up to 5 years after treatment. Researchers will measure immune-related side effects, event-free survival, tumor response, relapse rates, quality of life, swallowing function, and other long-term outcomes to evaluate the safety and effectiveness of this combined approach.
CONDITIONS
Brief Title
A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 21 years old or younger at study enrollment
- Newly diagnosed with American Joint Committee on Cancer (AJCC) stage II-IV nasopharyngeal carcinoma
- Histologic verification of malignancy at original diagnosis
- Lansky or Karnofsky performance status score of 60% or higher
- Peripheral absolute neutrophil count (ANC) of at least 1000/uL within 7 days before starting therapy
- Platelet count of at least 100,000/uL (transfusion independent) within 7 days before starting therapy
- Creatinine clearance or glomerular filtration rate (GFR) of at least 60 mL/min/1.73 m² within 7 days before therapy
- Serum creatinine within age- and sex-specific limits within 7 days before therapy
- Total bilirubin less than or equal to 1.5 times the upper limit of normal for age within 7 days before therapy
- Serum glutamic-pyruvic transaminase (SGPT/ALT) less than or equal to 135 U/L within 7 days before therapy
- Shortening fraction of 27% or higher by echocardiogram or ejection fraction of at least 50% by radionuclide angiogram
- No dyspnea at rest, no exercise intolerance, and pulse oximetry over 94% if assessed
- HIV-infected patients on effective therapy with undetectable viral load and normal T-cell count
- Patients with controlled hepatitis B or treated hepatitis C with undetectable viral loads
You will not qualify if you...
- Prior radiotherapy to the head or neck
- Prior chemotherapy or radiation for any cancer within the last 3 years unless in remission
- Diagnosis of immunodeficiency
- Active autoimmune disease requiring systemic treatment within the past 2 years
- Use of systemic corticosteroids or immunosuppressive medications within specified recent timeframes
- History or current non-infectious pneumonitis requiring steroids
- Detectable viral load of HIV, hepatitis B or C, or active tuberculosis
- History of solid organ or allogeneic hematopoietic transplant
- Pregnancy or breastfeeding without agreement to avoid pregnancy or breastfeeding during the study
- Failure to provide informed consent or meet all regulatory requirements for human studies
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 weeks
Participants receive nivolumab, gemcitabine, and cisplatin through intravenous infusions in 3 cycles repeated every 21 days, unless disease progression or unacceptable side effects occur.
3 cycles with visits on days 1 and 8 of each cycle
Duration - Approximately 9 weeks
Participants receive nivolumab and cisplatin infusions every 21 days for 3 cycles combined with concurrent radiation therapy, unless disease progression or unacceptable side effects occur.
3 cycles with day 1 visits plus concurrent radiation therapy visits
Duration - Approximately 24 weeks
Participants receive nivolumab infusions every 28 days for 6 cycles unless disease progression or unacceptable side effects occur.
6 visits every 28 days
Duration - Up to 5 years
Participants are monitored after treatment completion with visits to assess health, imaging, and quality of life for up to 5 years.
Every 3 months for 12 months, every 6 months until 24 months off therapy, then yearly visits
Trial Site Locations
Total: 85 locations
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
3
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202-3591
Actively Recruiting
4
Kaiser Permanente Downey Medical Center
Downey, California, United States, 90242
Actively Recruiting
5
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Actively Recruiting
6
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
7
Valley Children's Hospital
Madera, California, United States, 93636
Actively Recruiting
8
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
Actively Recruiting
9
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Actively Recruiting
10
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
Actively Recruiting
11
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
12
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
13
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Actively Recruiting
14
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
Actively Recruiting
15
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
16
UF Health Cancer Institute - Gainesville
Gainesville, Florida, United States, 32610
Actively Recruiting
17
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
18
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Suspended
19
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Actively Recruiting
20
Nemours Children's Hospital
Orlando, Florida, United States, 32827
Actively Recruiting
21
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States, 32504
Actively Recruiting
22
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States, 33607
Actively Recruiting
23
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States, 30329
Suspended
24
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
25
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Actively Recruiting
26
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
27
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Not Yet Recruiting
28
Children's Hospital New Orleans
New Orleans, Louisiana, United States, 70118
Actively Recruiting
29
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074
Actively Recruiting
30
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
31
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
32
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
33
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
34
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
35
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
36
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
37
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States, 68114
Actively Recruiting
38
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
39
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
40
Jersey Shore Medical Center
Neptune City, New Jersey, United States, 07753
Actively Recruiting
41
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
42
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Actively Recruiting
43
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
44
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
45
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Actively Recruiting
46
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
47
East Carolina University
Greenville, North Carolina, United States, 27834
Actively Recruiting
48
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
49
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
50
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
51
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States, 44106
Actively Recruiting
52
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
53
Dayton Children's Hospital
Dayton, Ohio, United States, 45404
Actively Recruiting
54
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
55
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
56
Penn State Children's Hospital
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
57
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
58
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
59
Prisma Health Richland Hospital
Columbia, South Carolina, United States, 29203
Actively Recruiting
60
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States, 29605
Actively Recruiting
61
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Actively Recruiting
62
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
63
The Children's Hospital at TriStar Centennial
Nashville, Tennessee, United States, 37203
Suspended
64
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
65
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Actively Recruiting
66
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
67
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
68
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
69
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
70
Children's Hospital of San Antonio
San Antonio, Texas, United States, 78207
Actively Recruiting
71
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
72
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507
Actively Recruiting
73
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
74
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
75
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, United States, 98405
Actively Recruiting
76
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
77
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Actively Recruiting
78
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
79
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
80
The Montreal Children's Hospital of the MUHC
Montreal, Quebec, Canada, H3H 1P3
Actively Recruiting
81
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
Actively Recruiting
82
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
83
Starship Children's Hospital
Grafton, Auckland, New Zealand, 1145
Actively Recruiting
84
Christchurch Hospital
Christchurch, New Zealand, 8011
Actively Recruiting
85
University Pediatric Hospital
San Juan, Puerto Rico, 00926
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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