Actively Recruiting
Consolidation Nivolumab After Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma
Led by Yonsei University · Updated on 2026-01-27
57
Participants Needed
1
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Consolidation Nivolumab After Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female
- Age 19 years or older at time of consent
- Histologically or cytologically confirmed advanced nasopharyngeal cancer (Stage II-IVa) before chemoradiotherapy
- Recovery from prior chemoradiotherapy toxicities (Grade 641)
- ECOG performance status 0 or 1
- Life expectancy of at least 3 months
- Laboratory values within specified limits within 7 days before registration (white blood cells 652,000/mm3, neutrophils 651,500/mm3, platelets 65100,000/mm3, hemoglobin 659.0 g/dL, AST and ALT 643.0-fold ULN or 645.0-fold with liver metastases, total bilirubin 641.5-fold ULN, creatinine 641.5-fold ULN or creatinine clearance >45 mL/min)
- Women of childbearing potential must agree to use effective contraception from consent until 5 months after last dose and not breastfeed
- Men must agree to use contraception from treatment start until 7 months after last dose
You will not qualify if you...
- Multiple primary cancers except certain fully treated types or cancers without recurrence for 5 years
- Residual adverse effects of prior therapy or surgery affecting safety evaluation
- History of severe hypersensitivity to antibody products
- Current or past autoimmune disease
- History of interstitial lung disease or pulmonary fibrosis; stable radiation pneumonitis allowed
- Concurrent diverticulitis or symptomatic gastrointestinal ulcerative disease
- Symptomatic brain or meningeal metastases requiring treatment; asymptomatic allowed
- Pericardial fluid, pleural effusion, or ascites requiring treatment
- Uncontrollable tumor-related pain
- Recent transient ischemic attack, stroke, thrombosis, or thromboembolism within 180 days
- Significant uncontrolled cardiovascular disease or arrhythmia
- Current anticoagulant therapy excluding low-dose aspirin
- Uncontrollable diabetes mellitus
- Systemic infections requiring treatment
- Recent systemic corticosteroids or immunosuppressants within 28 days
- Antineoplastic therapy within 28 days
- Recent surgery or radiotherapy within specified timelines
- Positive tests for certain viral infections (HIV, HTLV-1, hepatitis B or C)
- Pregnancy or breastfeeding
- Prior treatment with nivolumab or related immunotherapies
- Inability to provide consent
- Other conditions deemed inappropriate by investigators
- History of hypersensitivity to nivolumab
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
H
Hye Ryun Kim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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