NCT07267338

Pembrolizumab + MRGOO3 as Neoadjuvant in NPC

Pembrolizumab Combined With MRG-003 as Neoadjuvant Treatment of EBV- Associated Locoregionally Advanced Nasopharyngeal Carcinoma: A Single-arm, Single-center, Prospective Phase II Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, single-group, open-label, phase II trial to evaluate the efficacy and safety of 3 cycles of neoadjuvant pembrolizumab and MRG003 followed by concurrent CCRT and 14 cycles of adjuvant pembrolizumab in EBV-associated locoregionally advanced nasopharyngeal carcinoma patients. The primary objective is to evaluate the Clinical Complete Response (cCR) rate of neoadjuvant pembrolizumab+MRG003 in EBV-associated locoregionally advanced nasopharyngeal carcinoma. The CT/MRI head and neck, chest, upper abdomen for cCR assessment will be performed on week 9±7 days between neoadjuvant therapy and pre CCRT. Each subject will participate in the trial from the time the subject signs the informed consent form (ICF) through the final protocol-specified contact. After a screening phase of up to 28 days, each subject will be assigned to receive treatment until disease progression is confirmed, unacceptable adverse event(s), intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the subject, or until subjects has received up to 3 cycles pembrolizumab + MRG003, followed Standard concurrent chemoradiotherapy (CCRT), followed up to 14 cycles pembrolizumab (approximately 1 year). After the end of treatment, each subject will be followed for the occurrence of adverse events. Subjects who discontinue for reasons other than disease progression will have post-treatment follow-up for disease status until disease progression is confirmed by the site per RECIST 1.1, initiating a non-study cancer treatment, withdrawing consent, or becoming lost to follow-up. All subjects will be followed by telephone for overall survival until death, withdrawal of consent or the end of the study.

Conditions

• NPC
• Locoregionally Advanced Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab & MRG003	After a screening phase of up to 28 days, each subject will be assigned to receive treatment until disease progression is confirmed, unacceptable adverse event(s), intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the subject, or until subjects has received up to 3 cycles pembrolizumab + MRG003, followed Standard concurrent chemoradiotherapy (CCRT), followed up to 14 cycles pembrolizumab.

Timeline

• Start date: 2026-06-01
• Primary completion: 2027-12-01
• Completion: 2029-06-01
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

1 site across 1 country: China