Actively Recruiting
A Phase III Study of Becotatug Vedotin (MRG003) in Combination With PD-1 Inhibitor Versus PD-1 Inhibitor for the Treatment of EGFR-positive, CPS61 Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma: a Multicenter, Randomized Controlled Trial
Led by Ming-Yuan Chen · Updated on 2026-04-13
430
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining Becotatug vedotin with a PD-1 inhibitor compared to using a PD-1 inhibitor alone in patients with EGFR-positive, CPS 61 resectable locally advanced head and neck squamous cell carcinoma. This phase III, randomized, open-label study involves patients eligible for surgery and aims to determine if the combination improves outcomes for this specific cancer type. Participants receive either Becotatug vedotin plus pucotenlimab or pucotenlimab alone as neoadjuvant treatment before surgery, followed by adjuvant therapy after radiotherapy. Surgery is performed 3-4 weeks after neoadjuvant treatment. Radiotherapy starts 4-6 weeks post-surgery, with doses adjusted based on risk classification. High-risk patients may also receive cisplatin chemotherapy during radiotherapy. The neoadjuvant and adjuvant drug treatments follow specific dosing schedules every 3 weeks. Throughout the study, participants undergo evaluations including event-free survival over 3 years as the primary outcome. Secondary measures include overall survival, metastasis-free survival, tumor response before surgery, and quality of life assessments at multiple time points up to 3 years. Safety is monitored by tracking treatment-related complications and surgical outcomes. The total study duration encompasses treatment and long-term follow-up to assess efficacy and safety over time.
CONDITIONS
Brief Title
Becotatug Vedotin (MRG003) in Combination With PD-1 Inhibitor Versus PD-1 Inhibitor for the Treatment of EGFR-positive, CPS≥1 Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form
- Untreated, histologically confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx, or larynx), EGFR-positive, CPS 61, with clinical stages as specified
- Eligible for curative-intent surgery as determined by the surgeon
- Age between 18 and 75 years
- ECOG performance status 0-1
- Life expectancy greater than 6 months
- At least one measurable lesion per RECIST 1.1
- Adequate organ function based on specific blood test criteria without recent blood transfusions or growth factors
- Baseline left ventricular ejection fraction 61 50% measured by MUGA or echocardiography
- Women of childbearing potential agree to use contraception during treatment and for 3 months after last dose
- Good compliance
You will not qualify if you...
- Pregnant or breastfeeding women
- History of allergy to PD-1 inhibitors
- History of other malignancies within past 5 years except certain cured skin, cervical, or thyroid cancers
- Residual toxicity from prior anti-tumor therapy beyond specified mild conditions
- Uncontrolled cardiac conditions including heart failure, unstable angina, recent myocardial infarction, or significant arrhythmias
- Grade 61 2 peripheral neuropathy
- Pulmonary embolism or deep vein thrombosis within 3 months prior to enrollment (excluding catheter-related thrombosis)
- Active bleeding, coagulation disorders, or on coumarin anticoagulants
- Known hypersensitivity to components of vibecotamab or severe reactions to prior anti-EGFR agents
- Receipt of investigational drugs, systemic corticosteroids above specified doses, live vaccines, major surgery, or severe trauma within defined periods before study drug
- Severe infections or active pulmonary inflammation requiring treatment
- Severe chronic pulmonary disease with respiratory failure or symptomatic bronchospasm
- History of active autoimmune diseases or syndromes except certain mild resolved conditions
- Immunodeficiency including HIV or history of organ or bone marrow transplantation
- Active tuberculosis infection or history without formal treatment
- Active hepatitis B or C infection
- Uncontrolled effusions requiring frequent drainage
- Known substance abuse or alcoholism
- Any condition deemed inappropriate by investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks (2 cycles, every 3 weeks)
Participants receive neoadjuvant therapy with Becotatug Vedotin combined with pucotenlimab or pucotenlimab alone prior to surgical resection.
2 visits (in-person, Day 1 of each 3-week cycle)
Duration - 1 day
Participants undergo radical surgery 3 to 4 weeks after completing neoadjuvant therapy, following re-evaluation by the surgeon.
1 visit (in-person surgery)
Duration - Approximately 6 to 7 weeks (30 to 35 fractions of radiotherapy)
Participants receive adjuvant radiotherapy starting 4 to 6 weeks after surgery. High-risk participants also receive cisplatin chemotherapy during radiotherapy.
Daily visits for radiotherapy sessions, plus 3 cisplatin infusions for high-risk participants
Duration - Up to approximately 36 weeks (12 cycles of Becotatug Vedotin or 15 cycles of pucotenlimab, every 3 weeks)
Participants receive adjuvant therapy with Becotatug Vedotin combined with pucotenlimab or pucotenlimab alone after radiotherapy.
Up to 12 to 15 visits every 3 weeks
Duration - Up to 3 years
Participants are monitored for treatment outcomes, survival, and quality of life for up to 3 years after completing treatment.
Regular follow-up visits with assessments every few months
Trial Site Locations
Total: 1 location
1
The Fifth Affiliated Hospital,Sun Yat-sen University
Zhuhai, Guangdong, China, 519099
Actively Recruiting
Research Team
M
Mingyuan Chen
R
Rui You
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here