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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Carboplatin — DRUG
  Given IV
• Cisplatin — DRUG
  Given IV
• Gemcitabine — DRUG
  Given IV
• Nivolumab — BIOLOGICAL
  Given IV
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Dec 9, 2020

Status verified

Sep 2025

Primary completion

Aug 15, 2023

Completion

Aug 15, 2023

Study Design

Enrollment

15 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (nivolumab, gemcitabine, cisplatin / carboplatin)
  Patients receive nivolumab IV over 30 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 30-60 minutes or carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 4 weeks, patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
• Active Comparator: Arm II (gemcitabine, cisplatin / carboplatin)
  Patients receive gemcitabine and cisplatin or carboplatin as in Arm I.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Baseline to the date of death or last follow-up. Maximum follow-up time was 2.3 years. ]

Locations (322)

Find similar trials in Birmingham, AL

Related Studies

• Blood Tests and Questionnaires in Studying Adherence to Preventative Swallowing Exercises in Participants With Metastatic Head and Neck Cancer
  Recruiting · M.D. Anderson Cancer Center · Houston, Texas
• Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
  PHASE2 · Recruiting · National Cancer Institute (NCI) · Dublin, California
• A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC)
  PHASE2 · Recruiting · National Cancer Institute (NCI) · Birmingham, Alabama
• Testing the Addition of the Drug BMX-001, a Radioprotector, or a Placebo to the Usual Chemoradiation Therapy for Patients With Head and Neck Cancer
  PHASE2 · Recruiting · NRG Oncology · Gilbert, Arizona