Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRG003 (Becotatug vedotin) and Toripalimab | Drug | — | UNRESOLVED |
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MRG003 + Toripalimab
- description
- Participants receive 2 cycles of neoadjuvant combination therapy with toripalimab plus MRG003 (Becotatug vedotin). After the neoadjuvant phase, radical surgery is performed. Postoperative management follows the same risk-adapted criteria as the control arm: participants with ENE or positive/inadequate margins receive adjuvant chemoradiotherapy, while those without receive adjuvant radiotherapy alone. During adjuvant radiotherapy, participants receive 3 cycles of concurrent toripalimab. After radiotherapy, all participants receive 12 cycles of adjuvant toripalimab maintenance therapy.
- interventionNames
- Drug: MRG003 (Becotatug vedotin) and Toripalimab
- Drug: Toripalimab
- type
- ACTIVE_COMPARATOR
- label
- Toripalimab Monotherapy
- description
- Participants receive 2 cycles of neoadjuvant toripalimab monotherapy. After the neoadjuvant phase, radical surgery is performed. Postoperative management is determined by pathology: participants with extranodal extension (ENE) or positive/inadequate margins receive adjuvant chemoradiotherapy (cisplatin 100 mg/m² every 3 weeks for 3 cycles plus radiotherapy at 60-70 Gy depending on risk), while those without receive adjuvant radiotherapy alone. During adjuvant radiotherapy, participants receive 3 cycles of concurrent toripalimab. After radiotherapy, all participants receive 12 cycles of adjuvant toripalimab maintenance therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
1. Histologically or cytologically confirmed head and neck squamous cell carcinoma (HNSCC), PD-L1 positive (CPS ≥ 1) 2. 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) 3. No prior antitumor treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy) 4. Age 18 to 70 years 5. ECOG performance status 0 or 1 6. 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 7. At least one measurable lesion per RECIST 1.1 8. Life expectancy ≥ 12 weeks 9. 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 10. Voluntary signed informed consent, good compliance, willing to undergo follow-up
References
Publications (0)
Data not yet available