A Multicenter, Open-label, Phase II Pan-Tumor Study in Patients Who Have Participated in Trials to Investigate Efficacy and Safety of ONO-4538 as Monotherapy or in Combination With Other Therapies and Are Continuing ONO-4538 Treatment (ONO-4538-98)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 59
- 试验地点
- 38
- 主要终点
- Incidence of Adverse Events (Aes)
研究概览
简要总结
This study is intended to confirm the long-term safety of ONO-4538 in pan-tumor participants being treated with ONO-4538 monotherapy or in Combination with Other Therapies in clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant who is being treated with ONO-4538 as monotherapy or in Combination with Other Therapies in clinical trials
- •Participant who is eligible for ONO-4538 monotherapy or in combination with other therapies as per the clinical trials, and/or investigator-assessed clinical benefit
排除标准
- •Participant judged to be incapable of providing consent for reasons such as concurrent dementia
- •Participant judged by the investigator to be inappropriate as participants of this study
研究组 & 干预措施
ONO-4538 Monotherapy cohort
480 mg of ONO-4538 IV Q4W or 240 mg of ONO-4538 IV Q2W per the investigator's choice
干预措施: ONO-4538 (Drug)
Combination therapy cohort
ONO-4538 at 360 mg IV Q3W or 480 mg IV Q4W, and Combination therapies (S-1 + Oxaliplatin [SOX] therapy , Capecitabine + Oxaliplatin [CapeOX] therapy , Bevacizumab or Temozolomide) selected by the principal investigator or subinvestigator in the Parent Study will be continued in this study.
干预措施: ONO-4538 (Drug)
Combination therapy cohort
ONO-4538 at 360 mg IV Q3W or 480 mg IV Q4W, and Combination therapies (S-1 + Oxaliplatin [SOX] therapy , Capecitabine + Oxaliplatin [CapeOX] therapy , Bevacizumab or Temozolomide) selected by the principal investigator or subinvestigator in the Parent Study will be continued in this study.
干预措施: oxaliplatin (Drug)
Combination therapy cohort
ONO-4538 at 360 mg IV Q3W or 480 mg IV Q4W, and Combination therapies (S-1 + Oxaliplatin [SOX] therapy , Capecitabine + Oxaliplatin [CapeOX] therapy , Bevacizumab or Temozolomide) selected by the principal investigator or subinvestigator in the Parent Study will be continued in this study.
干预措施: S-1 (Drug)
Combination therapy cohort
ONO-4538 at 360 mg IV Q3W or 480 mg IV Q4W, and Combination therapies (S-1 + Oxaliplatin [SOX] therapy , Capecitabine + Oxaliplatin [CapeOX] therapy , Bevacizumab or Temozolomide) selected by the principal investigator or subinvestigator in the Parent Study will be continued in this study.
干预措施: capecitabine (Drug)
Combination therapy cohort
ONO-4538 at 360 mg IV Q3W or 480 mg IV Q4W, and Combination therapies (S-1 + Oxaliplatin [SOX] therapy , Capecitabine + Oxaliplatin [CapeOX] therapy , Bevacizumab or Temozolomide) selected by the principal investigator or subinvestigator in the Parent Study will be continued in this study.
干预措施: bevacizumab (Drug)
Combination therapy cohort
ONO-4538 at 360 mg IV Q3W or 480 mg IV Q4W, and Combination therapies (S-1 + Oxaliplatin [SOX] therapy , Capecitabine + Oxaliplatin [CapeOX] therapy , Bevacizumab or Temozolomide) selected by the principal investigator or subinvestigator in the Parent Study will be continued in this study.
干预措施: temozolomide (Drug)
结局指标
主要结局
Incidence of Adverse Events (Aes)
时间窗: From Day 1 up to 28 days after the end of the treatment phase
(non)
次要结局
未报告次要终点