Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
35

Summary

Conditions
Nasopharyngeal Carcinoma
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 21 years and 80 years
Gender
Both males and females

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 chemoth...

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.

Tracking Information

NCT #
NCT03097939
Collaborators
National University, Singapore
Investigators
Principal Investigator: Darren, Wan-Teck Lim, MD National Cancer Centre, Singapore