Nivolumab + Chemoradiation in Stage II-IVB Nasopharyngeal Carcinoma (NPC)

Part of paid clinical trials in San Francisco, California.

Sponsor
Sue Yom
Study ID
NCT03267498
Phase
PHASE2
Status
Completed

Conditions

  • Nasopharyngeal Carcinoma

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Dosage 240mg of Nivolumab will be given intravenously over 60 minutes, every 14 days.
  • Cisplatin — DRUG
    Dosage 40 mg/m2 of cisplatin will be given intravenously over 30-60 minutes, every 7 days.
  • Radiation Therapy — RADIATION
    2.12 Gy/fraction x 33 fractions of radiation therapy will be given, daily Monday - Friday

Study Details

This phase II trial studies how well nivolumab and chemoradiotherapy works in treating patients with stage II-IVB nasopharyngeal cancer. Monoclonal antibodies, such as nivolumab, may block tumor growth in different ways by targeting certain cells. Chemoradiotherapy is the combination of chemotherapy and radiation therapy and may prevent the cancer from spreading when combined with nivolumab. Giving nivolumab and chemoradiotherapy may work better in treating patients with stage II-IVB nasopharyngeal cancer.

Key Dates

Start date
Feb 14, 2018
Status verified
Jan 2026
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024

Study Design

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

Arms

  • Experimental: Nivolumab + chemoradiation
    Patients receive nivolumab IV over 60 minutes on day 1 of courses 1-5 and 7-12. Treatment repeats every 14 days for 11 courses in the absence of disease progression or unacceptable toxicity. Beginning at course 2, patients undergo radiation therapy QD 5 days per week and receive cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 7 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Rate of Completion of All Adjuvant Immunotherapy [ Time Frame: Up to 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143-

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University of California, San Francisco· San Francisco, CA

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