NCT03267498

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

Nivolumab in Combination With Chemoradiation for Patients With Stage II-IVB Nasopharyngeal Carcinoma, A Phase II Study With Correlative Biomarkers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Sue Yom · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To establish the feasibility of treatment completion of a combined chemoradiation-nivolumab regimen followed by adjuvant nivolumab. SECONDARY OBJECTIVES: I. To determine the overall response rate at 1 year from end of treatment, as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. II. To determine the locoregional control rate at 1 year post-treatment. III. To determine the distant metastasis rate at 1 year post-treatment. IV. To determine the rate of Epstein-Barr virus (EBV) deoxyribonucleic acid (DNA) clearance at end of chemoradiation and at 1 year from end of treatment. V. To determine the acute and late toxicity rates according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5, including immune-related adverse events (AEs). VI. To assess patients' quality of life from baseline through 1 year from end of treatment. EXPLORATORY OBJECTIVES: I. To determine the overall survival rate at 5-year post-treatment. II. To determine whether programmed death-ligand 1 (PD-L1) -positive immunohistochemistry and novel quantitative assays correlate to clinical outcome. III. To determine if the density of infiltrating Cluster of differentiation 3 (CD3)+ T cells/μm2 correlates to clinical outcome. IV. To monitor immune changes by flow cytometry in the circulating T cell response to EBV antigens. V. To compare the change in the circulating T-cell repertoire by TCR sequencing and single-cell T-cell profiling. VI. To quantify treatment-induced changes over time in the circulating T cell immune response to EBV using T-cell receptor (TCR) sequencing and enzyme-linked immunospot (ELISPOT) assays. OUTLINE: Patients receive nivolumab intravenously (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 once daily (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. After completion of study treatment, patients are followed up at 1, 3, 6, 9, and 12 months for up to 1 year and then survival follow-up information may be collected via telephone calls, clinic follow-up visits, or medical records review for up to an additional 4 years. Survival and disease status will be collected until participant death, withdrawal, or if the participant is lost to follow-up.

Conditions

• Nasopharyngeal Carcinoma

Interventions

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

Timeline

• Start date: 2018-02-14
• Primary completion: 2024-10-31
• Completion: 2024-10-31
• First posted: 2017-08-30
• Last updated: 2026-01-12
• Results posted: 2026-01-12

Locations

2 sites across 2 countries: United States, Singapore

Regulatory

• FDA-regulated drug study