NCT07677475Not yet recruitingPhase 2
MRG003 Plus Toripalimab Versus Toripalimab as Neoadjuvant Therapy for PD-L1-Positive, Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma
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
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 65 (estimated)
- First submitted
- 23 Jun 2026
- Start date
- 10 Aug 2026
- Primary completion date
- 30 Jan 2029
- Lead sponsor
- Dongguan People's Hospital
- Diseases
- Head and neck cancer
- NCT number
- NCT07677475
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 65
- From 10 Aug 2026 to the primary completion date, 30 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Histologically or cytologically confirmed head and neck squamous cell carcinoma (HNSCC), PD-L1 positive (CPS ≥ 1)
- Treatment-naïve, pathologically confirmed stage III-IVA resectable non-oropharyngeal HNSCC (oral cavity, larynx, hypopharynx) OR HPV-negative oropharyngeal SCC, OR HPV-positive stage III T4N0-2 resectable oropharyngeal cancer (AJCC 8th edition)
- No prior antitumor treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy)
- Age 18 to 70 years
- ECOG performance status 0 or 1
- Adequate organ function within 14 days before first dose (no blood products or growth factors within 14 days):
- ANC ≥ 1.0 × 10⁹/L, Hb ≥ 90 g/L, PLT ≥ 75 × 10⁹/L
- ALT/AST ≤ 1.5 × ULN, total bilirubin ≤ 1.5 × ULN, ALP \< 2.5 × ULN
- CrCl ≥ 50 mL/min (Cockcroft-Gault)
- APTT and INR ≤ 1.5 × ULN
- At least one measurable lesion per RECIST 1.1
- Life expectancy ≥ 12 weeks
- Female subjects of childbearing potential and male subjects with reproductive potential must use medically accepted contraception during treatment and for 3 months after last dose
- Voluntary signed informed consent, good compliance, willing to undergo follow-up
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Tenth Affiliated Hospital of Southern Medical University (Dongguan People's Hospital) Coordinator of this site? Confirm its status | Dongguan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.