drugset / Trial / NCT04676789

Anti-PD-1 Antibody and Pegaspargase Combined With Radiotherapy in Early-Stage ENKTL

NCT04676789

Phase 2 Unknown 30 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

Summary

Aim of the trial is to evaluate the safety and efficacy of sintilimab and pegaspargase in combination with pegaspargase for the initial treatment of previously untreated patients with limited stage NK/T cell lymphoma.All eligible patients will be treated with sintilimab combined with pegaspargase administered every 3 weeks for 4 cycles followed by standard radiotherapy with or without concurrent sintilimab and pegaspargase administered every 3 weeks. After radiotherapy, patients with complete remission with positive plasma EBV-DNA or partial response will continue with sintilimab maintenance up to 2 years.

Timeline

Start
2021-09-01
Primary completion
2024-09-01
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegaspargase Protein / enzyme biologic 2500 unknown Intramuscular
Subject Sintilimab Monoclonal antibody 200 mg Intravenous