Study Using Nivolumab with Chemotherapy to Treat Nasopharyngeal Carcinoma (NPC)

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06064097

Provider View

This clinical trial is exploring the effects of combining nivolumab, an immunotherapy drug, with chemotherapy before radiation therapy in patients with nasopharyngeal carcinoma (NPC). The study aims to see if this combination can help the immune system fight cancer more effectively and reduce side effects, especially in children.

Patient Parameters

Program Overview

This phase II study is testing whether adding nivolumab, an immunotherapy drug, to chemotherapy can help treat nasopharyngeal carcinoma (NPC) more effectively. Nivolumab may help the immune system attack cancer cells, while chemotherapy drugs like gemcitabine and cisplatin work to stop cancer cells from growing and spreading. Radiation therapy is also used to kill cancer cells. Researchers want to see if this combination can improve treatment outcomes and reduce side effects, particularly in children.

Description

The main goal of this study is to evaluate the safety of combining chemotherapy drugs (cisplatin and gemcitabine) with nivolumab, an immune checkpoint inhibitor, in children, adolescents, and young adults with nasopharyngeal carcinoma (NPC). Researchers will monitor for any significant side effects related to the immune system.

Secondary goals include estimating the 2-year event-free survival rate for patients treated with this combination, followed by radiation and nivolumab maintenance therapy. The study will also assess how well the treatment works in shrinking tumors and its feasibility in young patients.

Exploratory goals involve estimating 5-year survival rates, comparing different imaging methods to assess treatment response, and evaluating the effects of different radiation therapies. The study will also look at both short-term and long-term side effects, including those related to the immune system and radiation, and assess quality of life and swallowing function over time.

Participants will receive nivolumab and chemotherapy in cycles, followed by radiation therapy. After completing the treatment, patients will be monitored regularly for up to five years to track their health and any side effects. The study will also collect samples for future research.

Eligibility Criteria

Inclusion Criteria

  • Must be 21 years old or younger.
  • Newly diagnosed with stage II-IV nasopharyngeal carcinoma (NPC).
  • Must have a confirmed diagnosis of NPC.
  • Recommended to submit tumor tissue for research purposes.
  • Must have a performance status score of 60% or higher, indicating the ability to carry out daily activities.
  • Must have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1000/uL.
    • Platelet count of at least 100,000/uL without needing a transfusion.
    • Kidney function with creatinine clearance or GFR of at least 60 mL/min/1.73 m².
    • Serum creatinine levels within specified limits based on age and gender.
    • Total bilirubin within 1.5 times the normal limit for age.
    • Liver enzyme levels within specified limits.
    • Heart function with a shortening fraction of at least 27% or ejection fraction of at least 50%.
    • No breathing difficulties at rest and good oxygen levels if needed.
  • HIV-positive patients must be on effective treatment with undetectable viral load and normal T-cell count.
  • Patients with hepatitis B or C must have undetectable viral loads if on treatment.

Exclusion Criteria

  • Previous radiation therapy to the head or neck.
  • Previous chemotherapy or radiation for any cancer in the last 3 years, unless in remission.
  • Diagnosis of immunodeficiency.
  • Active autoimmune disease requiring treatment in the past 2 years, except for well-controlled asthma.
  • Need for systemic steroids or immunosuppressive medications recently.
  • History of lung inflammation requiring steroids.
  • Detectable viral load of HIV, hepatitis B, or C, or active tuberculosis.
  • Previous organ or bone marrow transplant.
  • Females of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Males must agree to use effective contraception.
  • Lactating females must agree not to breastfeed during and after treatment.
  • Must sign informed consent and meet all regulatory requirements.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.