Pembrolizumab + MRGOO3 as Neoadjuvant in NPC

Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study ID
NCT07267338
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Locoregionally Advanced Nasopharyngeal Carcinoma
  • NPC

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab & MRG003 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Nov 2025
Primary completion
Dec 31, 2027
Completion
Jun 30, 2029

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    Participants will receive 3 cycles of neoadjuvant Pembrolizumab 200 mg IV every 3 weeks (Q3W) combined MRG003 2.0mg/kg IV Q3W followed by standard CCRT and adjuvant treatment of Pembrolizumab 200 mg IV Q3W up to 14 cycles.

Primary Outcome Measure

Clinical Complete Response (cCR) rate [ Time Frame: cCR assessment will be performed on week 9±7 days between neoadjuvant therapy and pre CCRT ]

Central Contacts