drugset / Trial / NCT03769467
Tabelecleucel in Combination With Pembrolizumab in Subjects With Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a multicenter, open-label, single-arm Phase 1B/2 study to assess the safety and efficacy of tabelecleucel in combination with pembrolizumab for the treatment of subjects with platinum-pretreated, recurrent/metastatic Epstein-Barr Virus-associated Nasopharyngeal Carcinoma (EBV+ NPC).
Timeline
- Start
- 2019-02-19
- Primary completion
- 2021-08-19
- Completion
- 2021-08-19
Outcome
Outcome not reported
Stopped: “Phase 1B part was completed with review of DLTs and cumulative safety data by Safety Data Review Committee and identification of a safe RP2D. Post-internal review, sponsor decided to terminate the study, and hence, Phase 2 part was not conducted.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | tabelecleucel | Cell therapy | 2e+06 cells/kg | Intravenous |