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Becotatug Vedotin (MRG003) With PD-1 Blockade and Chemoradiotherapy in High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma

NCT07524413 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 514

Last updated 2026-04-13

No results posted yet for this study

Summary

This randomized controlled trial aims to evaluate the efficacy and safety of Becotatug Vedotin (MRG003), an antibody-drug conjugate (ADC), combined with the PD-1 inhibitor Pucotenlimab as induction therapy for high-risk locoregionally advanced nasopharyngeal carcinoma (NPC), compared to the standard gemcitabine and cisplatin (GP) regimen combined with Pucotenlimab, followed by concurrent chemoradiotherapy (CCRT) and adjuvant immunotherapy.

Conditions

  • Nasopharyngeal Cancinoma (NPC)
  • Nasopharyngeal Cancer

Interventions

DRUG

Becotatug Vedotin

Induction Therapy: Becotatug Vedotin (MRG003) 2.0 mg/kg, intravenous infusion, Day 1 (3 cycles, Q3W)

DRUG

Pucotenlimab

Induction Therapy: Pucotenlimab 200 mg, intravenous infusion, Day 1 (3 cycles, Q3W); Adjuvant Therapy: Pucotenlimab 200 mg, intravenous infusion, Day 1 (6 cycles, Q3W)

DRUG

Gemcitabine + cisplatin (GP)

Induction Therapy (3 cycles, Q3W): Gemcitabine 1000 mg/m², intravenous infusion, Days 1 and 8 Cisplatin 80 mg/m², intravenous infusion, Day 1

RADIATION

intensity-modulated radiotherapy

70 Gy in 33 fractions, once daily, 5 days per week

DRUG

Cisplatin

Concurrent Cisplatin: 100 mg/m², intravenous infusion, Day 1 (2 cycles, Q3W) during radiation

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2030-04-30
Completion
2032-04-30

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Drugs

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 NCT07524413 on ClinicalTrials.gov