Phase III Trial of Becotatug Vedotin Plus PD-1 Inhibitor Versus PD-1 Inhibitor Alone for Treating EGFR-Positive, CPS 1 Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma

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.

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