Actively Recruiting
A Phase 2, Open-label Trial of 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
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical effects of nivolumab in patients with locally advanced nasopharyngeal carcinoma (NPC) who still have residual disease after completing standard chemoradiotherapy. This phase 2 open-label trial aims to study the safety and antitumor activity of nivolumab, an anti-PD-1 receptor antibody, in this patient group. The study is sponsored by Yonsei University and focuses on patients with advanced NPC stages II to IVa who have recovered from prior treatment toxicities. Participants will receive nivolumab as a consolidation treatment starting within 12 weeks after finishing concurrent chemoradiation therapy. The drug is given intravenously at a dose of 360 mg every 3 weeks. Treatment may continue for up to one year or until disease progression or unacceptable toxicity occurs. This single-arm study involves regular administration of nivolumab to evaluate its role following chemoradiotherapy. During the study, participants will undergo various assessments including tumor response checks every 3 months during treatment and every 6 months afterward, for up to 5 years. Researchers will monitor progression-free survival at 2 years, overall survival, treatment-related side effects, and detailed biomarker analyses from tumor and immune cells. Laboratory tests and gene expression studies will be conducted at screening, during treatment cycles, and at treatment end to understand the drug's impact. The total participation may last several years due to long-term follow-up evaluations.
CONDITIONS
Brief 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 and older at the time of informed consent
- Histologically- or cytologically-confirmed advanced Nasopharyngeal cancer (Stage II-IVa) before chemoradiotherapy
- Recovered from previous toxicities of standard chemoradiotherapy (Grade 1 or less)
- ECOG Performance Status Score 0 or 1
- Life expectancy of at least 3 months
- Laboratory values within specified limits within 7 days before registration, including white blood cells, neutrophils, platelets, hemoglobin, liver enzymes, bilirubin, and creatinine
- Women of childbearing potential must agree to use contraception and not breastfeed during and for 5 months after treatment
- Men must agree to use contraception during and for 7 months after treatment
You will not qualify if you...
- Multiple primary cancers except certain fully treated or non-recurrent cancers
- Residual adverse effects from prior therapies affecting safety evaluation
- Severe hypersensitivity to antibody products
- Current or past autoimmune diseases
- Interstitial lung disease or pulmonary fibrosis; stable radiation pneumonitis allowed
- Diverticulitis or symptomatic gastrointestinal ulcerative disease
- Brain or meningeal metastasis if symptomatic or requiring treatment
- Pericardial fluid, pleural effusion, or ascites requiring treatment
- Uncontrollable tumor-related pain
- Recent transient ischemic attack, stroke, thrombosis, or embolism within 180 days
- Significant cardiovascular disease or uncontrolled hypertension
- Receiving or requiring anticoagulant therapy (antiplatelet therapy allowed)
- Uncontrollable diabetes mellitus
- Systemic infections requiring treatment
- Recent use of systemic corticosteroids or immunosuppressants
- Recent antineoplastic drugs within 28 days
- Recent surgeries or radiotherapy within specified timeframes
- Positive tests for certain viral infections
- Pregnant or breastfeeding women
- Recent use of unapproved drugs
- Prior treatment with Nivolumab or similar antibodies
- Incapacity to provide informed consent
- Other investigator-determined inappropriate subjects
- History of hypersensitivity to Nivolumab
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive Nivolumab 360mg intravenously every 3 weeks as a consolidation therapy after chemoradiotherapy, for up to 1 year until disease progression or unacceptable toxicity.
Every 3 weeks during treatment
Duration - Up to 5 years
Participants are monitored for disease progression, survival, and safety outcomes after the end of treatment.
Every 3 months during the first year, then every 6 months up to 5 years
Trial Site Locations
Total: 1 location
1
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
H
Hye Ryun Kim
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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