RecruitingPhase 2NCT06019130

Nivolumab in Children and Adults With Nasopharyngeal Carcinoma

Nivolumab in Combination With Cisplatin and 5-Fluorouracil as Induction Therapy in Children and Adults With EBV-positive Nasopharyngeal Carcinoma

Sponsor

German Society for Pediatric Oncology and Hematology GPOH gGmbH

Enrollment

57 participants

Start Date

Jan 10, 2023

Study Type

INTERVENTIONAL

Conditions

Nasopharyngeal Cancer Nasopharyngeal Carcinoma Nasopharynx Cancer Nasopharyngeal Neoplasms

Summary

The purpose of this study is to assess whether the addition of the immune checkpoint inhibitor Nivolumab to induction chemotherapy will increase the percentage of patients with a complete response on MRI and PET after 3 cycles of induction therapy.

Eligibility

Min Age: 3 Years

Plain Language Summary

Simplified for easier understanding

This trial tests adding nivolumab (an immunotherapy drug) to standard chemotherapy and radiation for children, teens, and young adults with newly diagnosed nasopharyngeal carcinoma (a cancer of the upper throat), as well as adults with EBV-associated stage III–IV disease. **You may be eligible if...** - You are a child or adolescent (3–17 years) with any stage II or higher nasopharyngeal carcinoma, OR an adult (18+) with EBV-positive, stage III–IV nasopharyngeal carcinoma - This is a new (not recurrent) diagnosis and you have not yet had chemotherapy or radiation - You have adequate blood counts and organ function **You may NOT be eligible if...** - Your cancer is Stage I, or Stage II and you are over 25 - Your cancer has come back (recurrent disease) - You have previously received immunotherapy or checkpoint inhibitors - You have active autoimmune disease, HIV, or Hepatitis B or C - You are pregnant or breastfeeding - You have a significant hearing loss not caused by the tumor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNivolumab

Nivolumab during induction chemotherapy in all groups and during radiochemotherapy in patients with SD or PD after induction or metastases

DRUGCisplatin

Cisplatin during induction chemotherapy and during radiochemotherapy in all groups

DRUG5-Fluorouracil

5-Fluoruracil during induction chemotherapy in all groups except of adults \> 25 years with metastatic disease at diagnosis

DRUGGemcitabine

Gemcitabine during induction chemotherapy in patients \> 25 years with metastatic disease at diagnosis

RADIATIONRadiotherapy

After induction therapy in all patients

DRUGInterferon beta-1a

In patients \< 26 years after end of radiochemotherapy for 6 months

PROCEDUREMRI

At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy

PROCEDUREPET

At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy, either as PET-CT or PET-MRI

BEHAVIORALPatient-Reported Outcomes

For all patients at baseline, before radiochemotherapy, at day 100, and 2 years after enrolment

Locations(31)

Uniklinik RWTH Aachen, Department of Internal Medicine

Aachen, Germany

Uniklinik RWTH Aachen, Division of Pediatric Hematology, Oncology, Stem Cell Transplantation

Aachen, Germany

Department of Pediatric Oncology and Hematology, Charité University Medicine Berlin

Berlin, Germany

Evangelisches Klinikum Bethel, Children's Hospital

Bielefeld, Germany

Department of Pediatric Hematology and Oncology, University Hospital

Bonn, Germany

Department of Otorhinolaryngology, Head and Neck Surgery, University of Cologne

Cologne, Germany

Children's Hospital, Carl-Thiem Klinikum Cottbus

Cottbus, Germany

Clinic for Children and Adolescent Medicine, Klinikum Dortmund

Dortmund, Germany

Department of Internal Medicine, Klinikum Dortmund

Dortmund, Germany

Department of Pediatrics, University Hospital, Technische Universität Dresden

Dresden, Germany

Department fo Radiotherapy, University Hospital

Erlangen, Germany

Department of Pediatrics, University Hospital Erlangen

Erlangen, Germany

Department of Medical Oncology, West German Cancer Center, University Hospital Essen

Essen, Germany

Department of Pediatric Hematology and Oncology, University Hospital Essen

Essen, Germany

Department of Pediatrics, University Hospital

Frankfurt, Germany

Department of Pediatric Hematology/Oncology, University Hospital Freiburg

Freiburg im Breisgau, Germany

Department of Pediatric Oncology, Justus-Liebig University of Giessen

Giessen, Germany

Department of Pediatric Oncology, University Hospital

Göttingen, Germany

Department of Pediatric Hematology/Oncology, University Medicine Greifswald

Greifswald, Germany

Universitätsklinikum Halle, Klinik für Pädiatrie I

Halle, Germany

Department of Otorhinolaryngology, University Medical Center Hamburg-Eppendorf,

Hamburg, Germany

Department of Pediatric Oncology, University Children's Hospital

Hamburg, Germany

Department of Otorhinolaryngology, Jena University Hospital

Jena, Germany

Department of Pediatric Oncology, University Hospital Kiel

Kiel, Germany

Department of Pediatrics, University Hospital Mageburg

Magdeburg, Germany

Pediatric Hematology/Oncology, University Medicine Mainz

Mainz, Germany

Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim,

Mannheim, Germany

Department of Pediatric Hematology and Oncology, University Children's Hospital

Münster, Germany

Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Hospital

Regensburg, Germany

Universitätsklinikum Tübingen, Klinik für Pädiatrie I

Tübingen, Germany

Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Children's Hospital, University of Würzburg

Würzburg, Germany

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NCT06019130

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