drugset / Trial / NCT07267338
Pembrolizumab + MRGOO3 as Neoadjuvant in NPC
Phase 2
Not yet recruiting
35 enrolled
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lepu Medical Technology (Beijing) Co., Ltd. · collabMerck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to evaluate efficacy and safety of neoadjuvant of the anti PD1 agent Pembrolizumab combined with MRG003 and adjuvant treatment of Pembrolizumab in patients with Epstein-Barr virus (EBV) - associated locoregionally advanced nasopharyngeal carcinoma. The expected sample size is 35 patients. Participants will receive 3 cycles of neoadjuvant pembrolizumab 200mg Q3W plus MRG003 2.3mg/kg Q3W followed by the standard concurrent chemoradiotherapy. Then participants will receive 14 cycles of adjuvant Pembrolizumab 200 mg Q3W after the standard concurrent chemoradiotherapy. The estimated average length of treatment per patients is 1 year.
Timeline
- Start
- 2026-06
- Primary completion
- 2027-12
- Completion
- 2029-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Becotatug Vedotin | Monoclonal antibody | 2 mg/kg | Intravenous |
| Subject | Becotatug Vedotin | Monoclonal antibody | 2.3 mg/kg | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |