drugset / Trial / NCT04417166
Pembrolizumab and Radiotherapy for Patients With NK/T Cell Lymphoma
Phase 2
Active not recruiting
30 enrolled
International Extranodal Lymphoma Study Group (IELSG)
Merck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment
Summary
Aim of the trial is to evaluate the activity and tolerability of the anti PD1 agent Pembrolizumab in combination with RadioTherapy for the initial treatment of previously untreated patients with limited stage NK/T cell lymphoma who are not eligible to chemotherapy. It is planned to enroll 30 patients in chinese sites. All eligible patients will be treated with standard radiotherapy and concurrent pembrolizumab administered intravenously every 3 weeks. After 6 cycles of pembrolizumab patients with complete remission, partial response and stable disease will continue with pembrolizumab maintenance up to 2 years. Patients will be followed up to 4 years from treatment start.
Timeline
- Start
- 2022-02-11
- Primary completion
- 2026-12
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |