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MRG003 Plus Toripalimab Versus Toripalimab as Neoadjuvant Therapy for PD-L1-Positive, Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma
Sponsor: Dongguan People's Hospital
Summary
This is a multicenter, prospective, randomized, controlled Phase II trial evaluating the safety and efficacy of MRG003 (Becotatug vedotin) combined with Toripalimab versus Toripalimab alone as neoadjuvant therapy for PD-L1-positive, resectable locally advanced head and neck squamous cell carcinoma. A total of 65 subjects are planned (43 experimental, 22 control). The experimental arm receives two cycles of MRG003 (Becotatug vedotin) 2.0 mg/kg intravenously on Day 1 followed by Toripalimab 240 mg intravenously on Day 1 every 3 weeks, while the control arm receives two cycles of Toripalimab 240 mg alone. After neoadjuvant therapy, both arms undergo radical surgery 3-4 weeks later, followed by risk-adapted adjuvant radiotherapy or chemoradiotherapy with concurrent Toripalimab (3 cycles) and then 12 cycles of adjuvant Toripalimab maintenance. The primary endpoint is the major pathological response rate.
Official title: MRG003 (Becotatug Vedotin) Plus Toripalimab Versus Toripalimab as Neoadjuvant Therapy for PD-L1-Positive, Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma: A Multicenter, Prospective, Randomized, Controlled Phase II Trial
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
65
Start Date
2026-06-30
Completion Date
2029-06-30
Last Updated
2026-07-31
Healthy Volunteers
No
Conditions
Interventions
MRG003 (Becotatug vedotin) and Toripalimab
Toripalimab 240 mg administered intravenously over 30-60 minutes on Day 1 of each 3-week cycle, followed immediately by MRG003 (Becotatug vedotin) 2.0 mg/kg (based on actual body weight) administered intravenously without prophylactic premedication. Neoadjuvant phase: 2 cycles of both drugs. Adjuvant toripalimab: 3 cycles concurrent with radiotherapy, then 12 cycles maintenance. For MRG003 (Becotatug vedotin), monitor infusion reactions for at least 120 minutes after first dose and at least 60 minutes after subsequent doses if tolerated. Dose reduction of MRG003 (Becotatug vedotin) to 1.5 mg/kg is permitted once for toxicity; permanent discontinuation if intolerance persists at reduced dose. Toripalimab dose remains fixed throughout; no dose modification is permitted.
Toripalimab
Toripalimab 240 mg administered intravenously over 30-60 minutes on Day 1 of each 3-week cycle. Neoadjuvant phase: 2 cycles. Adjuvant phase (concurrent with radiotherapy): 3 cycles. Adjuvant maintenance (after radiotherapy): 12 cycles. No prophylactic premedication required. No dose modification of toripalimab is permitted.
Locations (1)
The Tenth Affiliated Hospital of Southern Medical University (Dongguan People's Hospital)
Dongguan, Guangdong, China