A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC)
This study is for children, teenagers, and young adults (up to 21 years old) with a type of head and neck cancer called nasopharyngeal carcinoma (NPC). We're testing a new approach that combines a drug called nivolumab with standard chemotherapy, followed by radiation therapy. Nivolumab is an immunotherapy drug that helps your body’s own immune system fight cancer cells. Chemotherapy drugs, like gemcitabine and cisplatin, work by slowing down or stopping cancer cell growth. Radiation therapy uses high-energy rays to kill cancer cells. The main goals are to see how safe this combination treatment is, how well it works against the cancer, and if we can use less radiation for younger patients to reduce side effects. We also want to understand the long-term effects and quality of life for those participating.
At a glance
What is this study about?
This research study is looking for a better way to treat nasopharyngeal carcinoma, a type of cancer that starts in the upper part of the throat behind the nose. It's specifically for young patients, including children, teenagers, and young adults up to the age of 21, who have been newly diagnosed with this cancer.
The study combines a newer type of drug called nivolumab with standard chemotherapy and radiation. Nivolumab is an immunotherapy, which means it helps your body's immune system recognize and attack cancer cells. Think of it like giving your immune system a boost to fight off the cancer. The chemotherapy drugs, gemcitabine and cisplatin, are also powerful medicines that work to stop cancer cells from growing, dividing, and spreading. After this initial treatment, patients will also receive radiation therapy, which uses targeted energy to kill any remaining cancer cells and shrink tumours.
Researchers want to see if adding nivolumab to the usual chemotherapy and radiation can improve treatment outcomes. They are particularly interested in finding out how safe this combination is and how well it helps control the cancer. A very important goal for younger patients is to see if they can receive effective treatment with less radiation, which could help reduce long-term side effects and improve their quality of life. The study will also carefully check for any side effects and how patients are feeling throughout their treatment.
Key takeaways
- The study is for young people (up to 21) with nasopharyngeal cancer.
- It combines a new immune-boosting drug (nivolumab) with standard chemotherapy and radiation.
- The main aims are to check safety, how well it works, and if radiation can be reduced for children.
- Participation involves treatment, regular tests, and questionnaires on your well-being.
- You can stop participating at any time.
Who may be eligible?
This study is looking for children, teenagers, and young adults who are 21 years old or younger. You must have been newly diagnosed with nasopharyngeal carcinoma, which is a type of cancer in the upper part of the throat.
Your doctors will need to confirm the cancer type from a tissue sample. You'll also need to be well enough to take part in the study, which doctors will check using a specific health score and by looking at your blood tests. Your blood counts (like white blood cells and platelets) and how well your kidneys and liver are working need to be within a healthy range.
There are also some other requirements, like having specific levels of a kidney function measure, that your doctors will carefully review to make sure this study is right for you. They will explain everything clearly.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Am I 21 years old or younger?
- Have I been newly diagnosed with nasopharyngeal carcinoma?
- Am I well enough to participate, as determined by my doctor's assessments?
- Are my blood tests (like blood counts, kidney, and liver function) within healthy ranges?
What does participation involve?
If you decide to take part in this study, you'll receive a combination of treatments. This usually starts with nivolumab and chemotherapy, followed by radiation therapy, and then more nivolumab for a period. You will have regular hospital visits for these treatments and check-ups.
Throughout the study, you'll have various tests to monitor your health and how the treatment is working. These may include blood tests, imaging scans such as CT, MRI, and PET scans, and X-rays. You might also have heart checks like echocardiograms. Researchers will also ask you to complete questionnaires to understand your quality of life during treatment. The total time you'll be involved in the study can vary, but your doctors will let you know the expected duration of treatment and follow-up.
Potential risks and benefits
Locations (85)
- Children's Hospital of AlabamaVerified postcodeBirmingham, United States· Recruiting
- Phoenix Childrens HospitalVerified postcodePhoenix, United States· Recruiting
- Arkansas Children's HospitalVerified postcodeLittle Rock, United States· Recruiting
- Kaiser Permanente Downey Medical CenterVerified postcodeDowney, United States· Recruiting
- Loma Linda University Medical CenterVerified postcodeLoma Linda, United States· Recruiting
- Children's Hospital Los AngelesVerified postcodeLos Angeles, United States· Recruiting
- Valley Children's HospitalVerified postcodeMadera, United States· Recruiting
- UCSF Benioff Children's Hospital OaklandVerified postcodeOakland, United States· Recruiting
- Kaiser Permanente-OaklandVerified postcodeOakland, United States· Recruiting
- Rady Children's Hospital - San DiegoVerified postcodeSan Diego, United States· Recruiting
- UCSF Medical Center-Mission BayVerified postcodeSan Francisco, United States· Recruiting
- Children's Hospital ColoradoVerified postcodeAurora, United States· Recruiting
Common questions
What is nasopharyngeal carcinoma (NPC)?
It's a type of cancer that starts in the nasopharynx, which is the upper part of your throat behind your nose.
What is nivolumab?
Nivolumab is a type of medicine called immunotherapy. It helps your body's own immune system fight the cancer cells.
Will I still get chemotherapy and radiation?
Yes, this study combines nivolumab with standard chemotherapy and radiation therapy.
Why are they studying this?
Researchers want to see if adding nivolumab makes the treatment more effective and if they can use less radiation for children to reduce long-term side effects.
Who can join this study?
This study is for children, teenagers, and young adults (up to 21 years old) who have been newly diagnosed with nasopharyngeal carcinoma.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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