Actively Recruiting
Nivolumab Combined With Cisplatin and 5-Fluorouracil as Induction Therapy in Children and Adults With EBV-Positive Nasopharyngeal Carcinoma
Led by German Society for Pediatric Oncology and Hematology GPOH gGmbH · Updated on 2024-05-16
57
Participants Needed
31
Research Sites
104 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
Researchers are evaluating whether adding the immune checkpoint inhibitor Nivolumab to induction chemotherapy improves the rate of complete response in patients with nasopharyngeal carcinoma, as seen on MRI and PET scans after three cycles of induction therapy. This phase 2 study includes children and adults with EBV-positive nasopharyngeal carcinoma, aiming to assess this combination's effect on tumor response and survival outcomes. Participants will receive Nivolumab at a dose of 4.5 mg/kg body weight (maximum 360 mg) every three weeks combined with standard induction chemotherapy. Children and adults without metastases receive cisplatin and 5-fluorouracil, while adults with metastatic disease receive cisplatin and gemcitabine. Depending on response, Nivolumab may continue during radiochemotherapy, followed by maintenance therapy with recombinant interferon beta-1a for six months in younger patients. During the study, patients undergo a two-week screening period before treatment begins. MRI and PET scans are performed at diagnosis and after induction therapy to evaluate tumor response. Researchers will monitor treatment-related side effects, survival rates over two years, and tumor PD-L1 expression. Patient-reported outcomes will be collected at baseline, before radiochemotherapy, at 100 days, and two years after enrollment. The total study duration includes induction therapy, radiochemotherapy, maintenance, and follow-up assessments.
CONDITIONS
Brief 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 according to WHO classification in children aged 3-17 years or EBV-positive nasopharyngeal carcinoma in adults 18 years and older
- Stage II or higher for patients 25 years and 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 patients or legal guardians
You will not qualify if you...
- Nasopharyngeal carcinoma stage I in all patients or stage II in patients older than 25 years
- Recurrent nasopharyngeal carcinoma
- Nasopharyngeal carcinoma as a second malignancy with prior chemotherapy or radiotherapy
- Prior chemotherapy and/or radiotherapy
- Presence of other active malignancies
- Prior treatment with immune checkpoint inhibitors or drugs targeting T-cell pathways
- 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 requiring systemic treatment
- Use of systemic corticosteroids or immunosuppressive drugs within 14 days before therapy
- Positive tests for hepatitis B or C indicating acute or chronic infection
- Known HIV infection or AIDS
- Abnormal blood counts or liver, kidney function outside defined limits
- Significant hearing loss unrelated to tumor
- Allergy or hypersensitivity to platinum drugs or study components
- Uncontrolled heart disease
- Recent live vaccine within 4 weeks before study drug
- Karnofsky or Lansky performance score below 60
- Other illnesses or medications affecting study evaluation
- Pregnancy or lactation
- Institutionalization by legal order
- Inability or unwillingness to follow study procedures
- Mental or legal incapacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9 weeks
Participants receive Nivolumab combined with standard induction chemotherapy (cisplatin and 5-fluorouracil or gemcitabine depending on age and metastasis status) for up to 3 cycles. Nivolumab is given every three weeks during this period. MRI and PET scans are performed at diagnosis and 17 to 22 days after starting the third cycle of induction therapy.
3 treatment visits every 3 weeks; 2 imaging visits
Duration - Approximately 6 to 7 weeks
After induction therapy, participants undergo standard radiochemotherapy. Nivolumab is continued during radiochemotherapy for participants with stable disease, progressive disease, or metastatic disease, adding up to 3 further doses every three weeks. Cisplatin is administered during radiotherapy as per standard care.
Weekly visits during radiochemotherapy; up to 3 Nivolumab doses every 3 weeks
Duration - 6 months
Participants younger than 26 years receive maintenance therapy with recombinant interferon beta-1a for 6 months following radiochemotherapy.
Weekly injections for 6 months
Duration - Up to 2 years
Participants complete patient-reported outcome assessments at baseline, before radiochemotherapy, at day 100, and 2 years after enrollment to monitor overall health and survival.
4 visits for assessments
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
T
Tristan Römer, MD.
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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