Actively Recruiting
Nivolumab in Children and Adults With Nasopharyngeal Carcinoma
Led by German Society for Pediatric Oncology and Hematology GPOH gGmbH · Updated on 2024-05-16
57
Participants Needed
31
Research Sites
260 weeks
Total Duration
On this page
Sponsors
G
German Society for Pediatric Oncology and Hematology GPOH gGmbH
Lead Sponsor
D
Deutsche Krebshilfe e.V., Bonn (Germany)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nivolumab in Children and Adults With Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed new diagnosis of nasopharyngeal carcinoma in children and adolescents aged 3 to 17 years, or EBV-positive nasopharyngeal carcinoma in adults 18 years or older
- Stage II or higher disease for patients 25 years or younger; stage III or IV for patients older than 25 years
- Measurable disease by MRI according to RECIST 1.1 criteria
- Sufficient tumor tissue available for central review including PD-L1 staining
- Written informed consent obtained from patient and legal guardians if under 18 years
You will not qualify if you...
- Nasopharyngeal carcinoma stage I in all patients and stage II in patients older than 25 years
- Recurrent nasopharyngeal carcinoma
- Nasopharyngeal carcinoma as a second malignancy with prior chemotherapy or radiotherapy
- Prior chemotherapy or radiotherapy for nasopharyngeal carcinoma
- Other active malignancies
- Prior treatment with immune checkpoint inhibitors or similar antibodies
- Use of investigational drugs within 30 days before study entry
- Participation in another clinical trial
- History of organ transplant or bone marrow transplantation
- Active or suspected autoimmune disease except specific permitted conditions
- Recent systemic corticosteroid or immunosuppressive treatment
- Positive hepatitis B or C infection
- Known HIV/AIDS infection
- Inadequate blood, kidney, or liver function based on lab tests
- Hearing loss greater than 20 dB at 3 kHz from inner ear disorder
- Allergy to platinum compounds or study drugs
- Uncontrolled heart disease or recent arrhythmias
- Recent vaccination with live attenuated vaccines
- Karnofsky or Lansky performance score below 60
- Other illnesses or conditions posing unacceptable risk
- Pregnancy or lactation
- Legal or mental incapacity to consent or comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
Uniklinik RWTH Aachen, Department of Internal Medicine
Aachen, Germany, 52074
Actively Recruiting
2
Uniklinik RWTH Aachen, Division of Pediatric Hematology, Oncology, Stem Cell Transplantation
Aachen, Germany, 52074
Active, Not Recruiting
3
Department of Pediatric Oncology and Hematology, Charité University Medicine Berlin
Berlin, Germany, 13353
Active, Not Recruiting
4
Evangelisches Klinikum Bethel, Children's Hospital
Bielefeld, Germany, 33617
Active, Not Recruiting
5
Department of Pediatric Hematology and Oncology, University Hospital
Bonn, Germany, 53127
Not Yet Recruiting
6
Department of Otorhinolaryngology, Head and Neck Surgery, University of Cologne
Cologne, Germany, 50937
Actively Recruiting
7
Children's Hospital, Carl-Thiem Klinikum Cottbus
Cottbus, Germany, 03048
Actively Recruiting
8
Clinic for Children and Adolescent Medicine, Klinikum Dortmund
Dortmund, Germany, 44145
Active, Not Recruiting
9
Department of Internal Medicine, Klinikum Dortmund
Dortmund, Germany, 44145
Active, Not Recruiting
10
Department of Pediatrics, University Hospital, Technische Universität Dresden
Dresden, Germany, 01307
Active, Not Recruiting
11
Department fo Radiotherapy, University Hospital
Erlangen, Germany, 91054
Actively Recruiting
12
Department of Pediatrics, University Hospital Erlangen
Erlangen, Germany, 91054
Active, Not Recruiting
13
Department of Medical Oncology, West German Cancer Center, University Hospital Essen
Essen, Germany, 45147
Not Yet Recruiting
14
Department of Pediatric Hematology and Oncology, University Hospital Essen
Essen, Germany, 45147
Not Yet Recruiting
15
Department of Pediatrics, University Hospital
Frankfurt, Germany, 60590
Not Yet Recruiting
16
Department of Pediatric Hematology/Oncology, University Hospital Freiburg
Freiburg im Breisgau, Germany, 79106
Not Yet Recruiting
17
Department of Pediatric Oncology, Justus-Liebig University of Giessen
Giessen, Germany, 35392
Active, Not Recruiting
18
Department of Pediatric Oncology, University Hospital
Göttingen, Germany, 37075
Not Yet Recruiting
19
Department of Pediatric Hematology/Oncology, University Medicine Greifswald
Greifswald, Germany, 17475
Not Yet Recruiting
20
Universitätsklinikum Halle, Klinik für Pädiatrie I
Halle, Germany, 06120
Actively Recruiting
21
Department of Otorhinolaryngology, University Medical Center Hamburg-Eppendorf,
Hamburg, Germany, 20246
Actively Recruiting
22
Department of Pediatric Oncology, University Children's Hospital
Hamburg, Germany
Actively Recruiting
23
Department of Otorhinolaryngology, Jena University Hospital
Jena, Germany, 07743
Active, Not Recruiting
24
Department of Pediatric Oncology, University Hospital Kiel
Kiel, Germany, 24105
Actively Recruiting
25
Department of Pediatrics, University Hospital Mageburg
Magdeburg, Germany, 39120
Not Yet Recruiting
26
Pediatric Hematology/Oncology, University Medicine Mainz
Mainz, Germany, 55131
Active, Not Recruiting
27
Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim,
Mannheim, Germany, 68167
Actively Recruiting
28
Department of Pediatric Hematology and Oncology, University Children's Hospital
Münster, Germany, 48149
Active, Not Recruiting
29
Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Hospital
Regensburg, Germany, 93053
Not Yet Recruiting
30
Universitätsklinikum Tübingen, Klinik für Pädiatrie I
Tübingen, Germany, 72076
Actively Recruiting
31
Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Children's Hospital, University of Würzburg
Würzburg, Germany, 97080
Active, Not Recruiting
Research Team
H
Helena Kerp, PhD
CONTACT
T
Tristan Römer, MD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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