MRG003 Plus Toripalimab Versus Toripalimab as Neoadjuvant Therapy for PD-L1-Positive, Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma
Starting soon · Phase 2
Conditions studied: Head and Neck Squamous Cell Carcinoma
In brief
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.
Key facts
- Study ID
- NCT07677475
- Run by
- Dongguan People's Hospital
- People needed
- 65
- Starts
- 2026-08-10
- Expected to finish
- 2029-06-30
- Last updated by the study team
- 2026-08-05
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The Tenth Affiliated Hospital of Southern Medical University (Dongguan People's Hospital) — Dongguan, Guangdong, China
Full record on ClinicalTrials.gov
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