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Pembrolizumab + MRGOO3 as Neoadjuvant in NPC

NCT07267338 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-12-05

No results posted yet for this study

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.

Conditions

  • NPC
  • Locoregionally Advanced Nasopharyngeal Carcinoma

Interventions

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.

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Lepu Medical Technology (Beijing) Co., Ltd.

    collaborator INDUSTRY

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-12-31
Completion
2029-06-30

Countries

  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07267338 on ClinicalTrials.gov