drugset / Trial / NCT04230330

Nivolumab in Combination With GDP/ L-asparaginase in NK/ T-cell Lymphoma

NCT04230330

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a pilot study investigating the role of nivolumab, a PD-1 inhibitor, in the treatment of advanced stage or relapsed/refractory NKTL. Patients who have received PD-1 inhibitors will be excluded from this study. Patients who have a complete response or good partial response to nivolumab during initial phase will continue to be treated with nivolumab. Patients who have a partial response, stable disease, and progressive disease to nivolumab during initial phase will be treated with the combination of nivolumab and GDP/L-asparaginase.

Timeline

Start
2019-12-12
Primary completion
2020-06-12
Completion
2020-06-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 20 mg/m2 Intravenous
Subject Dexamethasone Small molecule 10 mg Intravenous
Subject Gemcitabine Small molecule 800 mg/m2 Intravenous
Subject Nivolumab Monoclonal antibody 240 mg Intravenous
Subject asparaginase Protein / enzyme biologic 6000 unknown Intravenous