NCT06064097 · National Cancer Institute (NCI)
A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC)
What this study is about
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.
View original scientific 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.
Interventions
PROCEDURE
Biopsy Procedure
Undergo tissue biopsy
PROCEDURE
Biospecimen Collection
Undergo blood and stool sample collection
PROCEDURE
Chest Radiography
Undergo chest x-ray
DRUG
Cisplatin
Given IV
PROCEDURE
Computed Tomography
Undergo CT
PROCEDURE
Echocardiography Test
Undergo ECHO
OTHER
Electronic Health Record Review
Ancillary studies
OTHER
Fluciclovine F18
Given IV
DRUG
Gemcitabine
Given IV
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
PROCEDURE
Multigated Acquisition Scan
Undergo MUGA
BIOLOGICAL
Nivolumab
Given IV
PROCEDURE
Positron Emission Tomography
Undergo PET
OTHER
Quality-of-Life Assessment
Ancillary studies
OTHER
Questionnaire Administration
Ancillary studies
RADIATION
Radiation Therapy
Receive radiation therapy
PROCEDURE
X-Ray Imaging
Undergo dental x-ray
Primary outcome measures
Incidence of grade 3 or higher immune-related adverse events (irAE) during induction chemoimmunotherapy (CIT)
Time frame: Until the end of consolidation therapy
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Birmingham, Alabama
- Phoenix, Arizona
- Little Rock, Arkansas
- Downey, California
- Loma Linda, California
- Los Angeles, California
- Madera, California
- Oakland, California
- San Diego, California
- San Francisco, California
- Aurora, Colorado
- Hartford, Connecticut
And 58 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 13, 2026 · Source of record for eligibility and locations