A Phase II Single Arm Clinical Study of Treprilimab in the Treatment of Local Recurrent/Residual Nasopharyngeal Carcinoma After Re-irradiation
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- objective response rate
研究概览
简要总结
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 modified Simon two-stage optimal design (α=0.05,β=0.2,n1=2/22,n2=7/40). If two responses were observed during the first stage, enrollment was continued until a total of 40 patients was reached.
详细描述
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 modified Simon two-stage optimal design (α=0.05,β=0.2,n1=2/22,n2=7/40). If two responses were observed during the first stage, enrollment was continued until a total of 40 patients was reached. The target lesions had to be measurable by the Response Evaluation Criteria in Solid Tumors (RECIST). Radiologic assessments were performed every 8 weeks for 6 months and then every 12 weeks thereafter. Eligible patients were treated with Treprilimab at a dosage of 240mg intravenously every 3 weeks until they experienced disease progression or unacceptable toxicity. The primary end point of this study was objective response by the RECIST criteria , and the secondary end points were overall survival (OS), progression-free survival (PFS), duration of response and toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages from 18 years to 65 years.
- •Histologically confirmed local recurrent/residual Nasopharyngeal carcinoma with previous re-irradiation.
- •measurable disease at baseline on the basis of RECIST v1.
- •Eastern Cooperative Oncology Group performance status of 0 or
- •adequate organ function.
- •anticipate survival≥3 months.
排除标准
- •a diagnosis of immuno deficiency or systemic corticosteroid therapy within 14 days of study start.
- •prior anticancer monoclonal antibody therapy within 4 weeks of study start.
- •any anticancer therapy within 4 weeks preceding the study start.
- •therapy with any other immune checkpoint inhibitor.
- •active autoimmune disease, interstitial lung disease, known additional malignancy that was progressing or that required active treatment.
- •not received platinum based chemotherapy previously.
- •confirmed systemic metastasis
- •HBV positive and Child-Pugh B or C cirrhosis
- •HCV positive and Child-Pugh B or C cirrhosis
研究组 & 干预措施
Treprilimab treatment group
Treprilimab 240mg ivdrip Q3W until progression or unacceptable toxicity
干预措施: Treprilimab (Drug)
结局指标
主要结局
objective response rate
时间窗: Response was assessed by magnetic resonance imaging every 8 weeks for the first 6 months and every 12 weeks thereafter.
the proportion of patients with confirmed complete response or partial response (PR) per RECIST v1.1
次要结局
- OS(time from enrollment to death from any cause)
- Number of participants with treatment-related adverse events(through the study and for 30 days after treatment discontinuation (90 days for serious AEs).)
- PFS(time from enrollment to the first documented progression of disease or death from any cause))
研究者
Fei Han
Deputy Director of radiotherapy Department
Sun Yat-sen University
