Study of Nivolumab, Cisplatin, and 5-Fluorouracil for Children and Adults with EBV-Positive Nasopharyngeal Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer called EBV-positive nasopharyngeal carcinoma, which affects the area behind the nose and above the back of the throat. The study involves a combination of treatments, including Nivolumab, Cisplatin, and 5-Fluorouracil. These medications are used as induction therapy, which means they are given at the beginning of treatment to help shrink the tumor before other treatments, like radiation, are used.

The purpose of the study is to see if this combination of medications can increase the number of patients who have a complete response, meaning no signs of cancer, as seen on imaging tests like MRI and PET-CT. This could potentially allow for a reduction in the amount of radiation therapy needed for children, adolescents, and young adults up to 25 years old with cancer that has not spread beyond the local area.

Participants in the study will receive the medications intravenously, which means they are given through a vein. The study will monitor the complete remission rate, which is the percentage of patients who show no signs of cancer after the treatment. It will also look at other outcomes like event-free survival, overall survival, and the safety and tolerability of the treatment. The study is expected to continue until 2028, with the goal of improving treatment outcomes for patients with this type of cancer.

1 joining the trial

Upon joining the trial, you will receive detailed information about the study and what to expect. You will be asked to provide written consent to participate.

If you are under 18, your legal guardians will need to provide consent on your behalf.

2 initial assessments

You will undergo initial assessments, including imaging tests like MRI and PET-CT, to measure the extent of the disease.

These tests help determine the starting point for your treatment and monitor progress throughout the trial.

3 treatment phase

You will receive a combination of medications: nivolumab, cisplatin, and 5-fluorouracil. These are administered through a vein, a process known as intravenous use.

The specific dosage and frequency of these medications will be determined by the medical team based on your individual needs and the trial protocol.

4 monitoring and follow-up

Throughout the trial, you will have regular follow-up appointments to monitor your response to the treatment.

These appointments will include repeat imaging tests and other assessments to evaluate the effectiveness of the therapy and any side effects.

5 completion of trial

At the end of the trial, a final assessment will be conducted to determine the overall outcome of the treatment.

You will receive information about the results and any further steps or treatments that may be recommended.

Who Can Join the Study?

Must have a new diagnosis of nasopharyngeal carcinoma confirmed by a test called a biopsy, which checks for cancer cells.
If you are between 3 and 17 years old, the diagnosis must be confirmed according to the current WHO classification.
If you are 18 years or older, the diagnosis must be EBV-positive nasopharyngeal carcinoma and classified as WHO stage II or III.
If you are 25 years or younger, the cancer must be stage II or higher. If you are older than 25, it must be stage III or IV, according to the AJCC, 8th edition.
The cancer must be measurable by an MRI scan, following specific guidelines called RECIST 1.1 criteria.
Written informed consent is required from legal guardians if the patient is under 18, and from the patient if they are 18 or older.
There must be enough tumor tissue available for a central review, including a test called PD-L1 staining. This requires either 2 full blocks or at least 25 slides from a biopsy or surgical specimen.

Who Cannot Join the Study?

Patients who do not have EBV-positive nasopharyngeal carcinoma cannot participate. This is a specific type of cancer in the nose and throat area.
Patients older than 25 years cannot participate.
Patients with diseases or conditions that make them unable to undergo magnetic resonance imaging (MRI) or PET-CT scans cannot participate. These are special imaging tests used to see inside the body.
Patients who cannot receive induction chemotherapy cannot participate. This is a type of cancer treatment given before the main treatment.
Patients who cannot have their radiotherapy dosage reduced from 59.4 Gy to 54 Gy cannot participate. Radiotherapy is a treatment that uses high doses of radiation to kill cancer cells.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Medicine Greifswald	Greifswald	Germany
University Hospital Jena KöR	Jena	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Universitaetsklinikum Magdeburg AöR	Magdeburg	Germany
Evangelisches Klinikum Bethel gGmbH	Bielefeld	Germany
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Klinikum Kassel GmbH	Kassel	Germany
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Klinikum Dortmund gGmbH	Dortmund	Germany
Universitaetsklinikum Aachen AöR	Aachen	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Johann Wolfgang Goethe University Clinic Frankfurt	Frankfurt	Germany
Ufhrtaaqsw Mhhgyxo Cleutr Hxnbouaukauysxaog	Hamburg	Germany
Ctxw Tscoy Kxisubgx gcduq	Cottbus	Germany
Uijasawjvj Hwohqytn Clugffl	Cologne	Germany
Ugefbsppmjrtcrdwwktpz Dgigtxcfdik Agj	Duesseldorf	Germany
Uedxqqltqhcakaskozhak Mfxgsgoe Aby	Munster	Germany
Utwesfkqcglfyzkyfoaqy Wxghxnmov Arh	Wuerzburg	Germany
Ulbnpmciqxeahwhslalnk Exnqc Aax	Essen	Germany
Mwjkqgorvyfyouyjkgkfiskqyn Hdxnczrbcqctcmsg	Halle (Saale)	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.09.2022

Trial locations

Investigated drugs:

Nivolumab is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, it is used to help treat nasopharyngeal carcinoma, a type of cancer that occurs in the upper part of the throat behind the nose.

Cisplatin is a chemotherapy drug that is used to kill cancer cells. It works by damaging the DNA inside the cancer cells, which stops them from growing and dividing. In this trial, cisplatin is used in combination with other treatments to help shrink the tumor before other therapies are applied.

5-Fluorouracil is another chemotherapy medication that is used to treat various types of cancer. It works by interfering with the cancer cells’ ability to make DNA and RNA, which are essential for their growth and survival. In this trial, 5-fluorouracil is used alongside other drugs to enhance the overall effectiveness of the treatment against nasopharyngeal carcinoma.

Investigated diseases:

Nasopharyngeal cancer

EBV-positive nasopharyngeal carcinoma – Epstein-Barr virus (EBV)-positive nasopharyngeal carcinoma is a type of cancer that occurs in the nasopharynx, the area behind the nose and above the back of the throat. It is associated with the presence of the Epstein-Barr virus in the cancer cells. The disease typically begins with symptoms such as a lump in the neck, nasal congestion, or nosebleeds. As it progresses, it may cause hearing loss, ear infections, or difficulty breathing. The cancer can spread to nearby tissues and lymph nodes. Over time, it may also metastasize to distant parts of the body.

Trial ID:

2022-500676-59-00

Protocol code:

NPC-Nivo

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Nivolumab, Cisplatin, and 5-Fluorouracil for Children and Adults with EBV-Positive Nasopharyngeal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?