Phase II Study of Becotatug Vedotin Added to Radiotherapy for Adults with Advanced Nasopharyngeal Cancer Not Responding Well to Induction Immunotherapy

What this Trial Is About

Researchers are evaluating the use of becotatug vedotin for patients with locally advanced nasopharyngeal carcinoma who have a suboptimal response to induction immunochemotherapy. This phase II clinical trial aims to provide additional treatment options during the concurrent radiotherapy and adjuvant phases for high-risk patients identified by poor response to initial therapy or plasma EBV DNA levels. The study is designed to gather evidence on the potential benefits of adding becotatug vedotin, which works differently from current treatments, to improve patient outcomes. The treatment plan includes three main phases. First, patients receive induction chemotherapy with docetaxel, cisplatin, and a PD-1 inhibitor every three weeks for three cycles. After a three-week break, concurrent radiotherapy begins with intensity-modulated radiotherapy IMRT combined with becotatug vedotin dosed at 2.3 mgkg every three weeks for three cycles. Following radiotherapy, an adjuvant phase starts four to six weeks later, where becotatug vedotin is again given every three weeks for three cycles. Participants will be closely monitored through various assessments including imaging and nasopharyngoscopy to evaluate treatment response. Researchers will measure progression-free survival over three years as the primary outcome. Secondary outcomes include overall survival, recurrence, metastasis-free survival, and the incidence of acute and late toxicities. The total study duration allows for long-term evaluation of safety and effectiveness of this treatment combination in eligible patients.

Becotatug Vedotin for LA-NPC With a Suboptimal Response to Induction Chemotherapy Combined With Immunotherapy