MedTrace Logo

Testing the Addition of an Anti-cancer Immune Therapy Drug (Nivolumab) to the Usual Chemotherapy Treatment (Cisplatin or Carboplatin With Gemcitabine) for Recurrent or Metastatic Nasopharyngeal Cancer

NCT04458909 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-10-03

Study results available
· View outcomes & findings →

Summary

This phase III trial compares the effect of adding nivolumab to the usual chemotherapy (cisplatin or carboplatin with gemcitabine) versus standard chemotherapy alone in treating patients with nasopharyngeal cancer that has come back (recurrent) or spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, carboplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab with the usual chemotherapy may work better than the standard chemotherapy alone in treating patients with nasopharyngeal cancer.

Conditions

  • Metastatic Nasopharyngeal Carcinoma
  • Metastatic Nasopharyngeal Keratinizing Squamous Cell Carcinoma
  • Metastatic Nasopharyngeal Nonkeratinizing Carcinoma
  • Metastatic Nasopharyngeal Undifferentiated Carcinoma
  • Nasopharyngeal Nonkeratinizing Carcinoma
  • Recurrent Nasopharyngeal Carcinoma
  • Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma
  • Recurrent Nasopharyngeal Undifferentiated Carcinoma
  • Stage IV Nasopharyngeal Carcinoma AJCC v8
  • Stage IVA Nasopharyngeal Carcinoma AJCC v8
  • Stage IVB Nasopharyngeal Carcinoma AJCC v8

Interventions

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

DRUG

Gemcitabine

Given IV

BIOLOGICAL

Nivolumab

Given IV

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • NRG Oncology

    collaborator OTHER

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Brigette B Ma · NRG Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-09
Primary Completion
2023-08-15
Completion
2023-08-15
FDA Drug
Yes

Countries

  • United States
  • Canada
  • China
  • Singapore

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 NCT04458909 on ClinicalTrials.gov