NCT04230330

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

A Pilot Study of Nivolumab in Combination With GDP (Gemcitabine, Dexamethasone, Cisplatin)/ L-asparaginase in Patients With Advanced Stage or Relapsed/ Refractory Natural-killer/ T-cell Lymphoma

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: National Cancer Centre, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NK/T Cell Lymphoma

Interventions

Type	Name	Description
DRUG	IV Nivolumab	240mg every 2 weeks.
DRUG	IV Nivolumab	Initial treatment dose is 240mg every 2 weeks for 4 doses. Dose changes to 360mg every 3 weeks when given with GDP/L-aspa. Maintenance treatment dose is 240mg every 2 weeks.
DRUG	IV Gemcitabine	800mg/m2 on Days 1 and 8 every 21 days
DRUG	IV Cisplatin	20mg/m2 on Day 1 to 4 every 21 days
DRUG	IV/PO Dexamethasone	10mg on Days 1 to 4 every 21 days
DRUG	IV L-asparaginase	6000 Units/m2 on Days 2 to 8 every 21 days

Timeline

• Start date: 2019-12-12
• Primary completion: 2020-06-12
• Completion: 2020-06-12
• First posted: 2020-01-18
• Last updated: 2020-11-05

Locations

1 site across 1 country: Singapore