Nivolumab in Children and Adults With Nasopharyngeal Carcinoma (NPC-Nivo)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Nasopharyngeal Carcinoma; Nasopharyngeal Cancer; Nasopharynx Cancer; Nasopharyngeal Neoplasms
• Intervention / Treatment: Drug: Nivolumab; Drug: Cisplatin; Drug: 5-Fluorouracil; Radiation: Radiotherapy; Drug: Interferon beta-1a; Procedure: MRI; Procedure: PET; Behavioral: Patient-Reported Outcomes; Drug: Gemcitabine

Detailed Description

After being informed about the study and potential risks, all patients will undergo a 2-week screening period to determine eligibility for study entry. After informed consent has been obtained, all patients ≤ 25 years and patients > 25 years without metastases will receive Nivolumab (4.5 mg/kg BW (max. 360 mg) q 3 weeks) added to standard induction chemotherapy (3 blocks of cisplatin/5-fluorouracil). In patients not responding to induction chemotherapy, the application of Nivolumab will be extended throughout the period of radiochemotherapy.

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.

• Study Type: Interventional
• Enrollment (Estimated): 57
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Helena Kerp, PhD; Phone Number: +49 201 74 94 96 14; Email: h.kerp@forschung-paediatrie.de
• Study Contact Backup: Name: Tristan Römer, MD.; Phone Number: +49 241 80 38063; Email: troemer@ukaachen.de

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Active, not recruiting
    • Uniklinik RWTH Aachen, Division of Pediatric Hematology, Oncology, Stem Cell Transplantation
  • Aachen, Germany, 52074
    • Recruiting
    • Uniklinik RWTH Aachen, Department of Internal Medicine
    • Contact: Mareike Tometten, MD; Phone Number: 0241-80-80703; Email: mtometten@ukaachen.de
  • Berlin, Germany, 13353
    • Active, not recruiting
    • Department of Pediatric Oncology and Hematology, Charité University Medicine Berlin
  • Bielefeld, Germany, 33617
    • Active, not recruiting
    • Evangelisches Klinikum Bethel, Children's Hospital
  • Bonn, Germany, 53127
    • Not yet recruiting
    • Department of Pediatric Hematology and Oncology, University Hospital
    • Contact: Dagmar Dilloo, MD; Phone Number: +49-228-287-33215; Email: dagmar.dilloo@ukbonn.de
  • Cottbus, Germany, 03048
    • Recruiting
    • Children's Hospital, Carl-Thiem Klinikum Cottbus
    • Contact: Georg Schwabe, MD; Phone Number: +49-355-46-2336; Email: G.Schwabe@ctk.de
  • Dortmund, Germany, 44145
    • Active, not recruiting
    • Clinic for Children and Adolescent Medicine, Klinikum Dortmund
  • Dortmund, Germany, 44145
    • Active, not recruiting
    • Department of Internal Medicine, Klinikum Dortmund
  • Dresden, Germany, 01307
    • Active, not recruiting
    • Department of Pediatrics, University Hospital, Technische Universität Dresden
  • Erlangen, Germany, 91054
    • Active, not recruiting
    • Department of Pediatrics, University Hospital Erlangen
  • Erlangen, Germany, 91054
    • Recruiting
    • Department fo Radiotherapy, University Hospital
    • Contact: Marlen Haderlein, MD; Phone Number: +49-9131-8533405; Email: st-studiensekretariat@uk-erlangen.de
  • Essen, Germany, 45147
    • Not yet recruiting
    • Department of Medical Oncology, West German Cancer Center, University Hospital Essen
    • Contact: Stefan Kasper-Virchow, MD; Phone Number: +49-201-72384150; Email: WTZI-Studie@uk-essen.de
  • Essen, Germany, 45147
    • Not yet recruiting
    • Department of Pediatric Hematology and Oncology, University Hospital Essen
    • Contact: Stefan Schönberger, MD; Phone Number: +49-201-723-85190.; Email: Stefan.Schoenberger@uk-essen.de
  • Frankfurt, Germany, 60590
    • Not yet recruiting
    • Department of Pediatrics, University Hospital
    • Contact: Konrad Bochennek, MD; Phone Number: +49-69-6301-4157; Email: Konrad.Bochennek@kgu.de
  • Freiburg, Germany, 79106
    • Not yet recruiting
    • Department of Pediatric Hematology/Oncology, University Hospital Freiburg
    • Contact: Simone Hettmer, MD; Phone Number: +49-761-270-46940; Email: simone.hettmer@uniklinik-freiburg.de
  • Giessen, Germany, 35392
    • Active, not recruiting
    • Department of Pediatric Oncology, Justus-Liebig University of Giessen
  • Greifswald, Germany, 17475
    • Not yet recruiting
    • Department of Pediatric Hematology/Oncology, University Medicine Greifswald
    • Contact: Karoline Ehlert, MD; Phone Number: +49-3834-866325; Email: karoline.ehlert@med.uni-greifswald.de
  • Göttingen, Germany, 37075
    • Not yet recruiting
    • Department of Pediatric Oncology, University Hospital
    • Contact: Christof Kramm, MD; Phone Number: +49-551-39-63081; Email: paedonko@med.uni-goettingen.de
  • Halle, Germany, 06120
    • Recruiting
    • Universitätsklinikum Halle, Klinik für Pädiatrie I
    • Contact: Jessica Höll, MD; Phone Number: +49-345-557-2388; Email: Jessica.Hoell@uk-halle.de
  • Hamburg, Germany, 20246
    • Recruiting
    • Department of Otorhinolaryngology, University Medical Center Hamburg-Eppendorf,
    • Contact: Henrike Zech, MD; Phone Number: +49-407-410-52364; Email: hzech@uke.de
  • Hamburg, Germany
    • Recruiting
    • Department of Pediatric Oncology, University Children's Hospital
    • Contact: Uwe Kordes, MD; Phone Number: +49-40-7410-53796; Email: u.kordes@uke.de
  • Jena, Germany, 07743
    • Active, not recruiting
    • Department of Otorhinolaryngology, Jena University Hospital
  • Kiel, Germany, 24105
    • Recruiting
    • Department of Pediatric Oncology, University Hospital Kiel
    • Contact: Simon Vieth, MD; Phone Number: +49-431-500-20119; Email: Simon.Vieth@uksh.de
  • Köln, Germany, 50937
    • Recruiting
    • Department of Otorhinolaryngology, Head and Neck Surgery, University of Cologne
    • Contact: Jens Klußmann, MD; Phone Number: +49-221-4784750; Email: jens.klussmann@uk-koeln.de
  • Magdeburg, Germany, 39120
    • Not yet recruiting
    • Department of Pediatrics, University Hospital Mageburg
    • Contact: Antje Redlich, MD; Phone Number: +49-391-67-24235; Email: Antje.Redlich@med.ovgu.de
  • Mainz, Germany, 55131
    • Active, not recruiting
    • Pediatric Hematology/Oncology, University Medicine Mainz
  • Mannheim, Germany, 68167
    • Recruiting
    • Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim,
    • Contact: Annette Affolter, MD; Phone Number: +49-621-383-3965; Email: annette.affolter@umm.de
  • Münster, Germany, 48149
    • Active, not recruiting
    • Department of Pediatric Hematology and Oncology, University Children's Hospital
  • Regensburg, Germany, 93053
    • Not yet recruiting
    • Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Hospital
    • Contact: Marcus Jakob, MD; Phone Number: +49-941-944-2101; Email: Marcus.Jakob@klinik.uni-regensburg.de
  • Tübingen, Germany, 72076
    • Recruiting
    • Universitätsklinikum Tübingen, Klinik für Pädiatrie I
    • Contact: Ines Brecht, MD; Phone Number: +49-7071-29-83773; Email: Ines.Brecht@med.uni-tuebingen.de
  • Würzburg, Germany, 97080
    • Active, not recruiting
    • Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Children's Hospital, University of Würzburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Histologically confirmed new diagnosis of nasopharyngeal carcinoma according to the current WHO classification in children and adolescents, aged between 3 years and 17 years, OR histologically confirmed new diagnosis of EBV-positive nasopharyngeal carcinoma, WHO stage II or III, in subjects ≥ 18 years
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:

1. Newly diagnosed nasopharyngeal carcinoma, Stage I in all patients, Stage II in patients > 25 years of age
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Nivolumab; Nivolumab during induction chemotherapy in all groups and during radiochemotherapy in patients with SD or PD after induction or metastases; Other Names: Opdivo; Drug: Cisplatin; Cisplatin during induction chemotherapy and during radiochemotherapy in all groups; Other Names: Cisplatin Teva; Drug: 5-Fluorouracil; 5-Fluoruracil during induction chemotherapy in all groups except of adults > 25 years with metastatic disease at diagnosis; Other Names: Fluorouracil-GRY; Radiation: Radiotherapy; After induction therapy in all patients; Drug: Interferon beta-1a; In patients < 26 years after end of radiochemotherapy for 6 months; Other Names: Rebif; Procedure: MRI; At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy; Procedure: PET; At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy, either as PET-CT or PET-MRI; Behavioral: Patient-Reported Outcomes; For all patients at baseline, before radiochemotherapy, at day 100, and 2 years after enrolment
Experimental: 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.	Drug: Nivolumab; Nivolumab during induction chemotherapy in all groups and during radiochemotherapy in patients with SD or PD after induction or metastases; Other Names: Opdivo; Drug: Cisplatin; Cisplatin during induction chemotherapy and during radiochemotherapy in all groups; Other Names: Cisplatin Teva; Drug: 5-Fluorouracil; 5-Fluoruracil during induction chemotherapy in all groups except of adults > 25 years with metastatic disease at diagnosis; Other Names: Fluorouracil-GRY; Radiation: Radiotherapy; After induction therapy in all patients; Drug: Interferon beta-1a; In patients < 26 years after end of radiochemotherapy for 6 months; Other Names: Rebif; Procedure: MRI; At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy; Procedure: PET; At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy, either as PET-CT or PET-MRI; Behavioral: Patient-Reported Outcomes; For all patients at baseline, before radiochemotherapy, at day 100, and 2 years after enrolment
Experimental: 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).	Drug: Nivolumab; Nivolumab during induction chemotherapy in all groups and during radiochemotherapy in patients with SD or PD after induction or metastases; Other Names: Opdivo; Drug: Cisplatin; Cisplatin during induction chemotherapy and during radiochemotherapy in all groups; Other Names: Cisplatin Teva; Drug: 5-Fluorouracil; 5-Fluoruracil during induction chemotherapy in all groups except of adults > 25 years with metastatic disease at diagnosis; Other Names: Fluorouracil-GRY; Radiation: Radiotherapy; After induction therapy in all patients; Procedure: MRI; At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy; Procedure: PET; At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy, either as PET-CT or PET-MRI; Behavioral: Patient-Reported Outcomes; For all patients at baseline, before radiochemotherapy, at day 100, and 2 years after enrolment
Experimental: 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.	Drug: Nivolumab; Nivolumab during induction chemotherapy in all groups and during radiochemotherapy in patients with SD or PD after induction or metastases; Other Names: Opdivo; Drug: Cisplatin; Cisplatin during induction chemotherapy and during radiochemotherapy in all groups; Other Names: Cisplatin Teva; Drug: 5-Fluorouracil; 5-Fluoruracil during induction chemotherapy in all groups except of adults > 25 years with metastatic disease at diagnosis; Other Names: Fluorouracil-GRY; Radiation: Radiotherapy; After induction therapy in all patients; Procedure: MRI; At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy; Procedure: PET; At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy, either as PET-CT or PET-MRI; Behavioral: Patient-Reported Outcomes; For all patients at baseline, before radiochemotherapy, at day 100, and 2 years after enrolment
Experimental: 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.	Drug: Nivolumab; Nivolumab during induction chemotherapy in all groups and during radiochemotherapy in patients with SD or PD after induction or metastases; Other Names: Opdivo; Drug: Cisplatin; Cisplatin during induction chemotherapy and during radiochemotherapy in all groups; Other Names: Cisplatin Teva; Radiation: Radiotherapy; After induction therapy in all patients; Procedure: MRI; At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy; Procedure: PET; At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy, either as PET-CT or PET-MRI; Behavioral: Patient-Reported Outcomes; For all patients at baseline, before radiochemotherapy, at day 100, and 2 years after enrolment; Drug: Gemcitabine; Gemcitabine during induction chemotherapy in patients > 25 years with metastatic disease at diagnosis; Other Names: Gemcitabin-GRY

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete remission rate after induction therapy	Complete response by MRI and PET will be determined as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria	MRI and PET will be done 17-22 days after start of induction therapy cycle 3 (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall and Event-free Survival	Overall and event-free survival rates will be analysed with suitable descriptive methods (Kaplan Meyer estimates with confidence intervals) and compared with historical data using descriptive log-rank tests	2 years after study enrolment
Number of Treatment-Related Adverse Events	Adverse events will be classified using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE) version 5.0 by investigator assessment. Descriptive methods (frequency tables, rates of AE's and SAE's with 95% confidence intervals) will be applied	At day 0 of chemotherapy cycles 1, 2 and 3, each; at day 20-25 after beginning of chemotherapy cycle 3 (each cycle is 21 days); within 2-3 weeks after the last dose of radiotherapy; 100 days following the last dose of Nivolumab
Efficacy based on PD-L1 expression in tumor tissue	PD-L1-stained % of tumor cells at the time of diagnosis will be associated to the rate of response after induction therapy and EFS and OS	Response to induction therapy will be measured 17-22 days after start of induction therapy cycle 3 (each cycle is 21 days), event-free and overall survival will be determined 2 years after study enrolment

Collaborators and Investigators

• Sponsor: German Society for Pediatric Oncology and Hematology GPOH gGmbH
• Collaborators: Deutsche Krebshilfe e.V., Bonn (Germany)
• Investigators: Principal Investigator: Udo Kontny, MD, Uniklinik RWTH Aachen

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Estimated): January 9, 2026
• Study Completion (Estimated): January 9, 2028

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Nivolumab; Children; Adults; Immunotherapy; Chemotherapy; Immune Checkpoint Inhibitor
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Carcinoma; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Adjuvants, Immunologic; Immune Checkpoint Inhibitors; Interferons; Cisplatin; Fluorouracil; Interferon beta-1a; Nivolumab; Interferon-beta; Gemcitabine
• Other Study ID Numbers: EUCT: 2022-500676-59-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No