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Phase 2 Trial of Ipilimumab and Nivolumab in Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:
A Phase II Trial Of Ipilimumab In Combination With Nivolumab In Patients With Advanced Nasopharyngeal Carcinoma

Clinical Trial Summary

The purpose of this study is to test the hypothesis that a combined Immuno-Oncology (IO) strategy would see efficacy in a virally driven cancer like Nasopharyngeal Carcinoma (NPC). Hence, this is a combination study of nivolumab and ipilimumab in Epstein-Barr virus (EBV) driven nasopharyngeal carcinoma.

Clinical Trial Description

Nasopharyngeal carcinoma (NPC) is endemic in Southern China and South-east Asia. Due to the peculiar chemosensitive nature of this disease and the low investment in drug development in Asia, there has been a paucity of new therapies for this disease. While response rates to repeated lines of chemotherapy average around 30%, the duration of disease control remains dismal and hence there is an unmet need to develop new therapies for this disease. These response rates are fairly similar to current monotherapy use of anti-PD1 agents in this group. Of specific interest, combined IO strategies have appear to add significantly to response rates in selected tumors such as melanoma, small cell lung cancer, and now Epidermal Growth Factor Receptor (EGFR) mutant lung cancers. It is hypothesized that a combined IO strategy would have similar if not better responses in a virally driven cancer like NPC. Hence this is a single arm study exploring the activity of a combination of nivolumab and ipilimumab in EBV driven nasopharyngeal carcinoma (NPC). The primary endpoint is best overall response rate. Secondary endpoints will examine clinical benefit rate at 18 weeks, toxicities of the combination, and immunological correlates. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03097939
Study type Interventional
Source National Cancer Centre, Singapore
Contact Darren, Wan-Teck Lim, MD
Phone +65 6436 8000
Email darren.lim.w.t@singhealth.com.sg
Status Recruiting
Phase Phase 2
Start date March 31, 2017
Completion date December 31, 2024
View Details
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