Phase III Trial of Becotatug Vedotin Plus Anti-PD-1 Antibody as Maintenance Therapy for Recurrent or Metastatic Nasopharyngeal Carcinoma

What this Trial Is About

Researchers are evaluating the efficacy and safety of combining becotatug vedotin with an anti-PD-1 antibody as maintenance therapy for adults aged 18 to 75 with recurrent or metastatic nasopharyngeal carcinoma who have stable disease or positive plasma EBV DNA after 4 to 6 cycles of first-line chemoimmunotherapy. This Phase III trial addresses the limited tumor control seen with single-agent PD-1 maintenance in this high-risk patient group. Participants are randomly assigned to one of two groups one receives only the anti-PD-1 antibody, and the other receives both anti-PD-1 antibody and becotatug vedotin. Treatments are given by intravenous infusion on Day 1 of each 21-day cycle and may continue for up to two years. Regular blood tests and tumor scans are performed to monitor the treatment effects and side effects. Biological samples will be collected with consent for biomarker research. During the study, participants will undergo assessments including tumor response evaluations and safety monitoring based on adverse event grading criteria. Researchers will measure progression-free survival as the primary outcome and also review overall survival, tumor responses, and treatment-emergent adverse events. Participants provide informed consent and can withdraw at any time without affecting their routine cancer care. The total study duration spans up to three years, including follow-up periods.

Efficacy and Safety of Becotatug Vedotin (MRG003) Combined With Anti-PD1 as Maintenance Therapy for Recurrent and Metastatic Nasopharyngeal Carcinoma