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Nivolumab in Children and Adults With Nasopharyngeal Carcinoma

ConditionsNasopharyngeal CarcinomaNasopharyngeal CancerNasopharyngeal NeoplasmsNasopharynx Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age3+
SponsorGerman Society for Pediatric Oncology and Hematology GPOH gGmbH

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Stage II or higher in patients ≤ 25 years of age, stage III and IV in patients > 25 years of age (AJCC, 8th edition)

Measurable disease by MRI per RECIST 1.1 criteria

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

Disqualifiers

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

Recurrent nasopharyngeal carcinoma

Nasopharyngeal carcinoma diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy

Prior chemotherapy and/or radiotherapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nivolumab

    Drug

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

  • Cisplatin

    Drug

    Cisplatin during induction chemotherapy and during radiochemotherapy in all groups

  • 5-Fluorouracil

    Drug

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

  • Gemcitabine

    Drug

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

  • Radiotherapy

    Radiation

    After induction therapy in all patients

  • Interferon beta-1a

    Drug

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

  • MRI

    Procedure/Surgery

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

  • PET

    Procedure/Surgery

    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

    Behavioral

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

Treatment groups

57 Participants
are divided into 5 treatment groups
Group A: Patients < 26 years with non-metastatic disease with CR or PR after induction therapyExperimental treatment 8 interventions
Group B: Patients < 26 y with no metastases and SD or PD after induction therapy or patients with metastasesExperimental treatment 8 interventions
Group C: Patients >25 years with non-metastatic disease with CR or PR after induction therapyExperimental treatment 7 interventions
Group D: Patients > 25 years with non-metastatic disease with SD or PD after induction therapyExperimental treatment 7 interventions
Group E: Patients > 25 years with metastatic disease at diagnosisExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
MRI and PET will be done 17-22 days after start of induction therapy cycle 3 (each cycle is 21 days)

Secondary outcomes

1

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

Time frame
2 years after study enrolment
2

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

Time frame
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
3

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

Time frame
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

German Society for Pediatric Oncology and Hematology GPOH gGmbH

Lead sponsor

RWTH Aachen University

Sponsor institution

Deutsche Krebshilfe e.V., Bonn (Germany)

Collaborator

Source ClinicalTrials.gov
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