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Nivolumab in Children and Adults With Nasopharyngeal Carcinoma

NCT06019130 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2024-05-16

No results posted yet for this study

Summary

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

  • Nasopharyngeal Carcinoma
  • Nasopharyngeal Cancer
  • Nasopharyngeal Neoplasms
  • Nasopharynx Cancer

Interventions

DRUG

Nivolumab

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

DRUG

Cisplatin

Cisplatin during induction chemotherapy and during radiochemotherapy in all groups

DRUG

5-Fluorouracil

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

DRUG

Gemcitabine

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

RADIATION

Radiotherapy

After induction therapy in all patients

DRUG

Interferon beta-1a

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

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

Sponsors & Collaborators

  • Deutsche Krebshilfe e.V., Bonn (Germany)

    collaborator OTHER

  • German Society for Pediatric Oncology and Hematology GPOH gGmbH

    lead OTHER

Principal Investigators

  • Udo Kontny, MD · Uniklinik RWTH Aachen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2026-01-09
Completion
2028-01-09

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06019130 on ClinicalTrials.gov