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Pembrolizumab & MRG003

Phase 2

NPC | Monoclonal antibody | Oncology |Merck & Company, Inc.|Trials Updated: Oct 21, 2026

Pembrolizumab & MRG003 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Dec 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

Pembrolizumab & MRG003 clinical trials

Pembrolizumab & MRG003 · 1 trial · 2 indications

Phase 2 1
NCT07267338Pembrolizumab + MRGOO3 as Neoadjuvant in NPCNPC
ACTIVE NOT_RECRUITING35 Analytics
PHASE2ACTIVE NOT_RECRUITING
Pembrolizumab + MRGOO3 as Neoadjuvant in NPC
NPC
NCT0726733835
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Study Endpoints

Primary Endpoints

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

clinical complete response (cCR) rate to neoadjuvant treatment.

Secondary Endpoints

Objective Response Rate (ORR)
To assess the objective response rate of Neoadjuvant therapy of Pembrolizumab in combination with MRG003 at maximum of 9 weeks (up to 3 cycles)
Event-Free Survival (EFS)
Defined as the time from date of treatment to the date of first documented disease progression that precluded definitive surgery, local or distant recurrence, occurrence of a second primary cancer or death from any cause, up to 36 months
Overall Survival (OS)
OS, defined as the time from the date of treatment to the date of death due to any cause, up to 60 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment groupEXPERIMENTALParticipants 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.

Interventions

NameTypeDescription
Pembrolizumab & MRG003DRUGAfter 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.
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Eligibility Criteria

SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of stage III-IVa (Exclude T3N0) nasopharyngeal carcinoma (NPC) will be enrolled in this study. 2. The participant (or legally acceptable re...

Countries:China
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