Nivolumab in Children and Adults With Nasopharyngeal Carcinoma
This research is investigating a new treatment approach for nasopharyngeal cancer, which is a type of cancer that starts in the upper part of your throat behind your nose. The study is testing whether adding a drug called Nivolumab to existing chemotherapy treatments can improve results. Nivolumab is an immunotherapy drug that works by helping your body's own immune system fight the cancer. We want to see if this combination leads to more patients having a complete response, where the cancer can't be seen on MRI or PET scans after treatment. Patients with newly diagnosed nasopharyngeal cancer, both children and adults, may be eligible. This is a Phase 2 study, which means it's still an early stage but is carefully testing the safety and effectiveness of this new combination.
At a glance
What is this study about?
This study is focusing on nasopharyngeal cancer, which is a type of cancer that affects the area at the back of your nose, where it meets your throat. Researchers are trying to find better ways to treat this condition, and this trial is exploring a new combination of treatments.
The main goal is to see if adding a medicine called Nivolumab to standard chemotherapy makes a significant difference. Nivolumab is a type of immunotherapy. Immunotherapy doesn't directly kill cancer cells like chemotherapy; instead, it helps your body's own immune system recognise and fight the cancer more effectively. The study wants to know if this combination helps more people achieve what's called a 'complete response.' This means that after a few rounds of treatment, doctors can't find any signs of the cancer on special scans like MRI and PET scans.
This trial is important because it could lead to improved outcomes for people with nasopharyngeal cancer. By helping your immune system, Nivolumab might make the chemotherapy more effective, potentially leading to better results and fewer relapses. This is a Phase 2 study, which means it's one of the earlier stages of drug testing. Researchers are carefully monitoring participants to understand both how well the treatment works and any potential side effects.
Key takeaways
- This study is testing Nivolumab with chemotherapy for nasopharyngeal cancer.
- Nivolumab is an immunotherapy aiming to boost your immune system against cancer.
- The main goal is to see if more patients achieve a 'complete response' on scans.
- It's for newly diagnosed patients, both children and adults, with certain cancer stages.
- This is an early-stage (Phase 2) study, carefully testing safety and effectiveness.
- You'll have regular medical checks and scans if you join.
Who may be eligible?
To join this study, you must have a new diagnosis of nasopharyngeal cancer that has been confirmed by a doctor. Your cancer also needs to be at a certain stage, generally Stage II or higher for younger patients (up to 25 years old) and Stage III or IV for older patients (over 25 years old). Doctors will also need to be able to measure your cancer on scans like an MRI, so they can track how well the treatment is working. We'll also need a small sample of your tumour tissue to do some tests.
There are some reasons why you wouldn't be able to join. For example, if your cancer is in a very early stage (Stage I), or if it's come back after being treated before, you wouldn't be eligible. Also, if you've had certain other cancers or received specific types of cancer treatment in the past, including some immunotherapy drugs, this study might not be right for you. Your medical team will carefully review all of your health information to see if you meet all the requirements.
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.
- Are you newly diagnosed with nasopharyngeal cancer?
- Is your cancer confirmed by a doctor?
- Is your cancer at Stage II or higher (if aged 25 or under) or Stage III/IV (if over 25)?
- Have you NOT had previous chemotherapy or radiotherapy for this cancer?
- Have you NOT had certain other immunotherapy drugs before?
- Are you aged 3 years or older?
What does participation involve?
If you decide to take part, you'll first have a screening period, which lasts about two weeks, to make sure this study is suitable for you. During this time, you'll have various tests and discussions with the study team. Once you're confirmed for the study and you've given your informed consent, you'll start treatment. This involves receiving the study drug, Nivolumab, along with standard chemotherapy drugs like cisplatin and 5-fluorouracil or gemcitabine. These will be given in cycles, usually through injections or infusions.
You'll have regular appointments to receive your treatment and to have scans like MRI and PET to check how the cancer is responding. The treatment phase, including chemotherapy and Nivolumab, will involve several blocks of treatment. If your cancer needs further treatment with radiotherapy, some patients may continue to receive Nivolumab during that time too. The total duration of your participation will depend on your specific treatment plan and how you respond, but it will involve ongoing follow-up to monitor your health and the cancer after the main treatment ends.
Potential risks and benefits
Locations (31)
- Uniklinik RWTH Aachen, Department of Internal MedicineVerified postcodeAachen, Germany· Recruiting
- Uniklinik RWTH Aachen, Division of Pediatric Hematology, Oncology, Stem Cell TransplantationVerified postcodeAachen, Germany· Active not recruiting
- Department of Pediatric Oncology and Hematology, Charité University Medicine BerlinVerified postcodeBerlin, Germany· Active not recruiting
- Evangelisches Klinikum Bethel, Children's HospitalVerified postcodeBielefeld, Germany· Active not recruiting
- Department of Pediatric Hematology and Oncology, University HospitalVerified postcodeBonn, Germany· Not yet recruiting
- Department of Otorhinolaryngology, Head and Neck Surgery, University of CologneVerified postcodeCologne, Germany· Recruiting
- Children's Hospital, Carl-Thiem Klinikum CottbusVerified postcodeCottbus, Germany· Recruiting
- Clinic for Children and Adolescent Medicine, Klinikum DortmundVerified postcodeDortmund, Germany· Active not recruiting
- Department of Internal Medicine, Klinikum DortmundVerified postcodeDortmund, Germany· Active not recruiting
- Department of Pediatrics, University Hospital, Technische Universität DresdenVerified postcodeDresden, Germany· Active not recruiting
- Department fo Radiotherapy, University HospitalVerified postcodeErlangen, Germany· Recruiting
- Department of Pediatrics, University Hospital ErlangenVerified postcodeErlangen, Germany· Active not recruiting
Common questions
What is nasopharyngeal carcinoma?
It's a type of cancer that starts in the upper part of your throat, behind your nose.
What is Nivolumab?
Nivolumab is an immunotherapy drug that helps your body's immune system fight cancer.
What does 'complete response' mean?
It means doctors can't find any signs of cancer on your scans after treatment.
How long will I be in the study?
The length varies, depending on your treatment plan and how you respond, followed by ongoing monitoring.
Can I stop participating at any time?
Yes, you are free to leave the study at any point without it affecting your future medical care.
How to find out more
Helena Kerp, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.