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NCT07524413

Dynamic Plasma EBV DNA-Guided Risk-Adapted Treatment With Becotatug Vedotin (MRG003) Plus PD-1 Blockade in Locoregionally Advanced Nasopharyngeal Carcinoma

StatusNot Yet Recruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved at least 1 year 7 months later, primary endpoint(s) modified, and 1 more.

See at-risk trials from Sun Yat-sen University

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Enrollment reduced: 514 → 298 participants Show 10 more changesShow less
    • Primary endpoint(s) modified
    • Primary completion pushed from Apr 2030 to Dec 2031
    • Phase changed: Phase 3 → Phase 2
    • Start date: Apr 2026 to Dec 2026
    • Eligibility criteria expanded, about 36 words
    • Study completion pushed from Apr 2032 to Dec 2033
    • Interventions modified
    • Secondary endpoints: details revised at 8 of 8 entries
    • Study description expanded, about 64 words
    • Study title expanded, about 4 words
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Post-induction Therapy Complete Response Rate (post-IT CRR)
Timeframe: Within 9 to 21 days after the last dose of induction therapy
Event-Free Survival (EFS) in the High-Risk Group
Timeframe: 3 years & 5 years

Secondary (8)

Overall survival (OS)
Distant Metastasis-Free Survival (DMFS)
Locoregional Recurrence-Free Survival (LRRFS)
Adverse Events (AEs)
Patient-Reported Adverse Events (PRO-CTCAE)
Show 3 moreShow less
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
EORTC Quality of Life Questionnaire Head and Neck 35 (EORTC QLQ-H&N35, version 1)
Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N, Chinese version 4)

Arms and interventions

Low-Risk GroupExperimental

Participants with undetectable plasma cfEBV DNA and a radiographic complete response or partial response after three cycles of induction therapy \[Becotatug Vedotin (MRG003) 2.0 mg/kg, intravenous infusion, Day 1 + Pucotenlimab 200 mg, intravenous infusion, Day 1; 3 cycles, Q3W\] are classified as low risk and receive the following treatment: Radiotherapy Alone: Intensity-modulated radiotherapy (IMRT), 70 Gy in 33 fractions, once daily, 5 days per week; Adjuvant Immunotherapy (5 cycles, Q3W): Pucotenlimab 200 mg, intravenous infusion, Day 1.

High-Risk GroupExperimental

Participants with detectable plasma cfEBV DNA or a radiographic response of stable disease or progressive disease after three cycles of induction therapy \[Becotatug Vedotin (MRG003) 2.0 mg/kg, intravenous infusion, Day 1 + Pucotenlimab 200 mg, intravenous infusion, Day 1; 3 cycles, Q3W\] are classified as high risk and receive the following treatment: Concurrent Chemoradiotherapy (CCRT): IMRT, 70 Gy in 33 fractions, once daily, 5 days per week + Cisplatin 100 mg/m², intravenous infusion, Day 1 (2 cycles, Q3W); Adjuvant Therapy: Pucotenlimab 200 mg, intravenous infusion, Day 1 (5 cycles, Q3W) + Capecitabine 650 mg/m², orally twice daily, Days 1-21 (17 cycles, Q3W).

Drugs: Becotatug Vedotin, Pucotenlimab, Cisplatin, Capecitabine

Radiation: Intensity-Modulated Radiotherapy