Consolidation Nivolumab After Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma

Sponsor
Yonsei University
Study ID
NCT04910347
Phase
PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced Nasopharyngeal Carcinoma

Eligibility Criteria

Sex
MALE
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Dosage within 12 weeks after the end of concurrent chemoradiation therapy. Nivolumab 360mg Intravenously administered every 3 weeks. As a consolidation regimen, administration of Nivolumab is administered for up to a total of 1 year until disease progression or unacceptable to toxicity occurs.

Study Details

The clinical efficacy of nivolumab for locally advanced nasopharyngeal carcinoma patients with residual disease after standard chemoradiotherapy is not known. In this study, we aim to investigate the role of nivolumab in locally advanced NPC after chemoradiotherapy the safety profile and antitumor activity of the anti-programmed death 1 (PD-1) receptor monoclonal antibody, nivolumab after in patients with advanced nasopharyngeal carcinoma

Key Dates

Start date
Feb 7, 2022
Status verified
Jan 2026
Primary completion
Apr 30, 2026
Completion
May 31, 2026

Study Design

Enrollment
57 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Nivolumab

Primary Outcome Measure

Progression-free survival (PFS) rate at 2years [ Time Frame: 2 years ]

Central Contacts