Nivolumab in Children and Adults With Nasopharyngeal Carcinoma
NCT ID: NCT06019130
Last Updated: 2024-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
57 participants
INTERVENTIONAL
2023-01-10
2028-01-09
Brief Summary
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Detailed Description
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Patients \> 25 years with metastatic disease will receive Nivolumab (4.5 mg/kg BW (max. 360 mg) q 3 weeks) added to induction chemotherapy with 3 blocks of cisplatin/gemcitabine.
All patients with metastatic disease will continue to receive Nivolumab during radiochemotherapy.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Patients < 26 years with non-metastatic disease with CR or PR after induction therapy
Participants receive Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 100 mg/m2 on day 1, plus 5-fluorouracil 1,000 mg/m2/d from day 1-5.
After induction therapy patients will undergo standard radiochemotherapy. Primary PTV1 including elective irradiated LN-levels, will be 45Gy, with a boost ad 59.4Gy in patients with PR or a reduced boost at 54Gy in patients with CR. Cisplatin will be administered at 3x20mg/m2 in the first and last week of radiotherapy, each.
Radiochemotherapy is followed by maintenance therapy with recombinant interferon-ß1a at 3x6Mio IU/week s.c. for 6 months.
Nivolumab
Nivolumab during induction chemotherapy in all groups and during radiochemotherapy in patients with SD or PD after induction or metastases
Cisplatin
Cisplatin during induction chemotherapy and during radiochemotherapy in all groups
5-Fluorouracil
5-Fluoruracil during induction chemotherapy in all groups except of adults \> 25 years with metastatic disease at diagnosis
Radiotherapy
After induction therapy in all patients
Interferon beta-1a
In patients \< 26 years after end of radiochemotherapy for 6 months
MRI
At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy
PET
At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy, either as PET-CT or PET-MRI
Patient-Reported Outcomes
For all patients at baseline, before radiochemotherapy, at day 100, and 2 years after enrolment
Patients < 26 y with no metastases and SD or PD after induction therapy or patients with metastases
Participants receive Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 100 mg/m2 on day 1, plus 5-fluorouracil 1,000 mg/m2/d from day 1-5. Patients with metastases responding to induction therapy may have a fourth cycle of induction therapy, including a fourth dose of Nivolumab.
After induction therapy patients will undergo standard radiochemotherapy. Primary PTV1 including elective irradiated LN-levels, will be 45Gy, with a boost ad 59.4Gy. Cisplatin will be administered at 3x20mg/m2 in the first and last week of radiotherapy, each. Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) will be continued during radiochemotherapy, adding a total of 3 further doses of Nivolumab.
Radiochemotherapy is followed by maintenance therapy with recombinant interferon-ß1a at 3x6Mio IU/week s.c. for 6 months.
Nivolumab
Nivolumab during induction chemotherapy in all groups and during radiochemotherapy in patients with SD or PD after induction or metastases
Cisplatin
Cisplatin during induction chemotherapy and during radiochemotherapy in all groups
5-Fluorouracil
5-Fluoruracil during induction chemotherapy in all groups except of adults \> 25 years with metastatic disease at diagnosis
Radiotherapy
After induction therapy in all patients
Interferon beta-1a
In patients \< 26 years after end of radiochemotherapy for 6 months
MRI
At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy
PET
At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy, either as PET-CT or PET-MRI
Patient-Reported Outcomes
For all patients at baseline, before radiochemotherapy, at day 100, and 2 years after enrolment
Patients >25 years with non-metastatic disease with CR or PR after induction therapy
Participants receive Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 100 mg/m2 on day 1, plus 5-fluorouracil 1,000 mg/m2/d from day 1-5.
After induction therapy patients will undergo standard radiochemotherapy as outlined in current international guidelines (e.g. NCCN, ESMO).
Nivolumab
Nivolumab during induction chemotherapy in all groups and during radiochemotherapy in patients with SD or PD after induction or metastases
Cisplatin
Cisplatin during induction chemotherapy and during radiochemotherapy in all groups
5-Fluorouracil
5-Fluoruracil during induction chemotherapy in all groups except of adults \> 25 years with metastatic disease at diagnosis
Radiotherapy
After induction therapy in all patients
MRI
At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy
PET
At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy, either as PET-CT or PET-MRI
Patient-Reported Outcomes
For all patients at baseline, before radiochemotherapy, at day 100, and 2 years after enrolment
Patients > 25 years with non-metastatic disease with SD or PD after induction therapy
Participants receive Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 100 mg/m2 on day 1, plus 5-fluorouracil 1,000 mg/m2/d from day 1-5.
After induction therapy patients will undergo standard radiochemotherapy as outlined in current international guidelines (e.g. NCCN, ESMO). Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) will be continued during radiochemotherapy, adding a total of 3 further doses of Nivolumab.
Nivolumab
Nivolumab during induction chemotherapy in all groups and during radiochemotherapy in patients with SD or PD after induction or metastases
Cisplatin
Cisplatin during induction chemotherapy and during radiochemotherapy in all groups
5-Fluorouracil
5-Fluoruracil during induction chemotherapy in all groups except of adults \> 25 years with metastatic disease at diagnosis
Radiotherapy
After induction therapy in all patients
MRI
At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy
PET
At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy, either as PET-CT or PET-MRI
Patient-Reported Outcomes
For all patients at baseline, before radiochemotherapy, at day 100, and 2 years after enrolment
Patients > 25 years with metastatic disease at diagnosis
Participants receive Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 80 mg/m2 on day 1, plus gemcitabine 1,000 mg/m2/d on day 1 and day 8, respectively. Patients responding to induction therapy may have a fourth cycle of induction therapy, including a fourth dose of Nivolumab.
After induction therapy patients will undergo standard radiochemotherapy as outlined in current international guidelines (e.g. NCCN, ESMO). Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) will be continued during radiochemotherapy, adding a total of 3 further doses of Nivolumab.
Nivolumab
Nivolumab during induction chemotherapy in all groups and during radiochemotherapy in patients with SD or PD after induction or metastases
Cisplatin
Cisplatin during induction chemotherapy and during radiochemotherapy in all groups
Gemcitabine
Gemcitabine during induction chemotherapy in patients \> 25 years with metastatic disease at diagnosis
Radiotherapy
After induction therapy in all patients
MRI
At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy
PET
At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy, either as PET-CT or PET-MRI
Patient-Reported Outcomes
For all patients at baseline, before radiochemotherapy, at day 100, and 2 years after enrolment
Interventions
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Nivolumab
Nivolumab during induction chemotherapy in all groups and during radiochemotherapy in patients with SD or PD after induction or metastases
Cisplatin
Cisplatin during induction chemotherapy and during radiochemotherapy in all groups
5-Fluorouracil
5-Fluoruracil during induction chemotherapy in all groups except of adults \> 25 years with metastatic disease at diagnosis
Gemcitabine
Gemcitabine during induction chemotherapy in patients \> 25 years with metastatic disease at diagnosis
Radiotherapy
After induction therapy in all patients
Interferon beta-1a
In patients \< 26 years after end of radiochemotherapy for 6 months
MRI
At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy
PET
At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy, either as PET-CT or PET-MRI
Patient-Reported Outcomes
For all patients at baseline, before radiochemotherapy, at day 100, and 2 years after enrolment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Stage II or higher in patients ≤ 25 years of age, stage III and IV in patients \> 25 years of age (AJCC, 8th edition)
3. Measurable disease by MRI per RECIST 1.1 criteria
4. Sufficient tumor tissue to be sent for central review, including PD-L1 staining, either as 1 or 2 full blocks (preferred) or a minimum of 25 slides, obtained from core biopsy, punch biopsy, excisional biopsy or surgical specimen
5. Written informed consent by legal guardians (if patient not ≥ 18 years) and patient prior to study participation
Exclusion Criteria
2. Recurrent nasopharyngeal carcinoma
3. Nasopharyngeal carcinoma diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy
4. Prior chemotherapy and/or radiotherapy
5. Other active malignancy
6. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
7. The subject received an investigational drug within 30 days prior to inclusion into this study
8. Subjects who are enrolled in another clinical trial
9. Subjects with prior organ allograft or allogenic bone marrow transplantation
10. Subjects with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrol.
11. Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days before start of therapy. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
12. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
13. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
14. Inadequate hematologic, renal or hepatic function defined by any of the following screening laboratory values:
1. WBC \< 2 000/µl
2. Neutrophils \< 1 500/µl
3. Platelets \< 100 x 10e3/µL
4. Hemoglobin \< 9.0 g/dL
5. Creatinine \>1.5 x ULN or creatinine clearance \< 50 mL/min (using the Cockcroft Gault formula or Schwartz formula in patients \< 18 years)
6. AST/ALT \> 3 x ULN (\> 5 x ULN if liver metastases)
7. Total Bilirubin \> 1.5 x ULN (except subjects with Gilbert Syndrome who must have a total bilirubin level ≥ 3.0 x ULN)
15. Hearing loss \> 20 dB loss at 3 kHz due to an inner ear disorder and not caused by tumour burden
16. History of allergy or hypersensitivity to platinum-containing compounds or other study drug components
17. Clinically significant, uncontrolled heart disease (including history of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months of screening).
18. Vaccinated with live attenuated vaccines within 4 weeks of the first dose of the study drug.
19. Adequate performance status (Karnofsky score ≥ 60 for patients (age ≥ 16), Lansky score ≥ 60 (age \< 16).
20. The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication.
21. The subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study.
22. Pregnant females as determined by positive \[serum or urine\] hCG test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol. (Please refer to section 4.4)
23. Lactating females
24. Subjects, who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities
25. The subject is unwilling or unable to follow the procedures outlined in the protocol
26. The subject is mentally or legally incapacitated.
3 Years
ALL
No
Sponsors
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Deutsche Krebshilfe e.V., Bonn (Germany)
OTHER
German Society for Pediatric Oncology and Hematology GPOH gGmbH
OTHER
Responsible Party
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Prof. Dr. Udo Kontny
Head, Div. Pediatric Hematology, Oncology, Stem Cell Transplantation
Principal Investigators
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Udo Kontny, MD
Role: PRINCIPAL_INVESTIGATOR
Uniklinik RWTH Aachen
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EUCT: 2022-500676-59-00
Identifier Type: -
Identifier Source: org_study_id
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