A Phase II Clinical Study of Treprilimab in the Treatment of Recurrent Nasopharyngeal Carcinoma After Re-irradiation
To establish the antitumor activity and safety of the anti-programmed death 1 receptor monoclonal antibody, Treprilimab, in patients with local recurrent/residual nasopharyngeal carcinoma after re-irradiation.Patients with local recurrent/residual NPC after re-irradiation were treated with Treprilimab until disease progression or unacceptable toxicity. The primary end point was objective response rate (ORR) and secondary end points included survival and toxicity.The sample size of this study was estimated on the assumption that response rates (RRs) to Treprilimab should be around 25%,based on a report that was available at the time this study was planned.Furthermore, the RR to noncytotoxic, experimental agents such as pazopanib and cetuximab in similarly pretreated patient cohorts was approximately 5% to 10%. This study's design was based on the modi?ed Simon two-stage optimal design (?=0.05??=0.2,n1=2/22,n2=7/40). If two responses were observed during the ?rst stage, enrollment was continued until a total of 40 patients was reached.
Start: September 2020