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
Study ID
NCT07677475
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • MRG003 (Becotatug vedotin) and Toripalimab — DRUG
    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 — DRUG
    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.

Study Details

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 Dates

First listed
Jun 30, 2026
Start date
Aug 10, 2026
Status verified
Jul 2026
Primary completion
Jan 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
65 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MRG003 + Toripalimab
    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.
  • Active Comparator: Toripalimab Monotherapy
    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.

Primary Outcome Measure

Major Pathological Response (MPR) rate [ Time Frame: At the time of surgical specimen evaluation (approximately 6-8 weeks after initiation of neoadjuvant therapy) ]

Central Contacts

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