Clinical trial for Stage II Nasopharyngeal Carcinoma AJCC v8
Official title A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC)
ClinicalTrials.gov ID: NCT06064097
What this study is testing
What is Cisplatin?
Cisplatin is an investigational chemotherapy drug being studied for the treatment of stage II nasopharyngeal carcinoma in combination with nivolumab and gemcitabine. Cisplatin is designed to damage DNA in cancer cells, preventing them from dividing.
Also referred to as DDP, CDDP.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how adding the immunotherapy drug nivolumab to standard chemotherapy affects patients with newly diagnosed nasopharyngeal cancer, looking at both benefits and side effects.
- Who it's for
- Adults with stage II, III, or IV nasopharyngeal carcinoma who have not yet received treatment.
- What's involved
- Participants receive a combination of nivolumab and chemotherapy drugs, followed by radiation therapy. They will have regular clinic visits and medical tests to monitor treatment response and side effects.
- Time commitment
- The study lasts about 6 to 12 months, with multiple scheduled visits for drug administration, imaging scans, and health assessments.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 21
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
See the full eligibility 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)
- 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 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).
- 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.
- 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.
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Downey, California, United States
- Loma Linda, California, United States
- Los Angeles, California, United States
- Madera, California, United States
- Oakland, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Hartford, Connecticut, United States
- Wilmington, Delaware, United States
- Washington D.C., District of Columbia, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Pensacola, Florida, United States
- Tampa, Florida, United States
+ 58 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, up to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Downey, California, United States; Loma Linda, California, United States; Los Angeles, California, United States and 72 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.