MRG003 Plus Toripalimab Versus Toripalimab as Neoadjuvant Therapy for PD-L1-Positive, Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma

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.

NCT Number	NCT07677475
Lead Sponsor	Dongguan People's Hospital Collaborators: Sun Yat-Sen University Cancer Center, Shenzhen People's Hospital, Peking University Shenzhen Hospital, The University of Hong Kong-Shenzhen Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Huizhou Municipal Central Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions	Head and Neck Squamous Cell Carcinoma
Enrollment	65 participants
Start Date	2026-08-10
Primary Completion	2029-01-30 (estimated)
Study Completion	2029-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-05