Nivolumab + Chemoradiation in Stage II-IVB Nasopharyngeal Carcinoma (NPC)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Nasopharyngeal Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Single-arm, open label clinical trial of concurrent and adjuvant nivolumab, including a run-in phase to establish basic feasibility of the nivolumab schedule followed by expansion.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 completion of therapy, as determined by Response Evaluation Criter...
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 completion of therapy, 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 overall survival rate at 1 year post-treatment. V. To determine the rate of Epstein-Barr virus (EBV) deoxyribonucleic acid (DNA) clearance at end of chemoradiation and at 1 year post-treatment. VI. To assess patients' quality of life from baseline through 1 year post-treatment. VII. 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). 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 for 100 days, at 1, 3, 6, 9, and 12 months for up to 1 year, and then every 3 months for 1 year.
Tracking Information
- NCT #
- NCT03267498
- Collaborators
- National University Cancer Institute, Singapore
- Bristol-Myers Squibb
- Investigators
- Principal Investigator: Sue S Yom, MD, PhD University of California, San Francisco