Nivolumab in Treating Patients With Recurrent and/or Metastatic Nasopharyngeal Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02339558
Phase
PHASE2
Status
Completed

Conditions

  • Nasopharyngeal Nonkeratinizing Carcinoma
  • Recurrent Nasopharynx Carcinoma
  • Stage III Nasopharyngeal Carcinoma AJCC v7
  • Stage IV Nasopharyngeal Carcinoma AJCC v7
  • Stage IVA Nasopharyngeal Carcinoma AJCC v7
  • Stage IVB Nasopharyngeal Carcinoma AJCC v7
  • Stage IVC Nasopharyngeal Carcinoma AJCC v7

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

This phase II trial studies how well nivolumab works in treating patients with nasopharyngeal cancer that has returned after a period of improvement (recurrent) and/or has spread to other parts of the body (metastatic). Monoclonal antibodies, such as nivolumab, may block tumor growth in different ways by targeting certain cells.

Key Dates

Start date
Jul 21, 2015
Status verified
Aug 2019
Primary completion
Jun 16, 2018

Study Design

Enrollment
45 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (nivolumab)
    Patients receive nivolumab IV over approximately 60 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Confirmed Response Rate (Complete Response or Partial Response) Based on RECIST Version 1.1 [ Time Frame: Up to 3 years ]

Locations (15)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-
Los Angeles County-USC Medical CenterLos AngelesCalifornia90033-
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Keck Medical Center of USC PasadenaPasadenaCalifornia91105-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
City of Hope South PasadenaSouth PasadenaCalifornia91030-
Moffitt Cancer CenterTampaFlorida33612-
Northwestern UniversityChicagoIllinois60611-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
UC Comprehensive Cancer Center at Silver CrossNew LenoxIllinois60451-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
University of Maryland/Greenebaum Cancer CenterBaltimoreMaryland21201-
Mayo ClinicRochesterMinnesota55905-
Mayo Clinic Cancer Center P2CRochesterMinnesota55905-
Washington University School of MedicineSt LouisMissouri63110-

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