NCT07524413

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

A Randomized, Controlled, Multicenter, Phase III Trial of Becotatug Vedotin in Combination With PD-1 Blockade Plus Chemoradiotherapy Versus PD-1 Blockade Plus Chemoradiotherapy in Patients With High-Risk Locoregionally Advanced Nasopharyngeal Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 514 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients in the experimental arm will receive MRG003 (2.0 mg/kg, Day 1, Q3W × 3 cycles) plus Pucotenlimab (200 mg, Day 1, Q3W × 3 cycles) as induction therapy, followed by CCRT \[intensity-modulated radiotherapy (IMRT): 70 Gy in 33 fractions, 5 days/week, once daily; cisplatin 100 mg/m², Day 1, Q3W × 2 cycles\], and adjuvant Pucotenlimab (200 mg, Day 1, Q3W × 6 cycles). Patients in the control arm will receive gemcitabine (1000 mg/m², Days 1 and 8, Q3W × 3 cycles) plus cisplatin (80 mg/m², Day 1, Q3W × 3 cycles) and Pucotenlimab (200 mg, Day 1, Q3W × 3 cycles) as induction therapy, followed by the same CCRT regimen and adjuvant Pucotenlimab. The primary objectives are to assess whether ADC-based induction therapy improves the post-induction therapy complete response rate (post-IT CRR) and event-free survival (EFS) compared to the GP-based standard of care. Secondary objectives include comparisons of overall survival (OS), distant metastasis-free survival (DMFS), and locoregional recurrence-free survival (LRRFS), as well as evaluation of the safety, tolerability, and quality of life associated with the MRG003-containing regimen.

Conditions

• Nasopharyngeal Cancinoma (NPC)
• Nasopharyngeal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-01
• Primary completion: 2030-04-01
• Completion: 2032-04-01
• First posted: 2026-04-13
• Last updated: 2026-04-13