An Open-label, Multi-center, Rollover Study in Subjects With Advanced Solid Tumor Malignancies After Participation in a Vopratelimab (JTX-2011) Clinical Study
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 3
- 主要终点
- Percentage of Subjects With Adverse Events (AEs)
研究概览
简要总结
JTX-2011-R01 is an open label, multicenter, rollover study that is designed to provide continued access to vopratelimab for eligible subjects with advanced solid tumor malignancies who have previously participated in a vopratelimab study (the parent study).
详细描述
Vopratelimab is an agonist monoclonal antibody that specifically binds to the Inducible Co-Stimulator of T cells (ICOS) to generate an anti-tumor immune response. This is an open label, roll over study to evaluate the long-term safety of continued treatment with vopratelimab monotherapy or combination treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is currently receiving and tolerating vopratelimab (JTX-2011) therapy and receiving clinical benefit from study treatment in the opinion of the Investigator and/or Sponsor.
- •Subject has demonstrated compliance with the parent study requirements, as assessed by the Investigator and/or Sponsor, and is able and willing to comply with the necessary visits and assessments as part of the rollover study.
- •Written informed consent must be obtained prior to enrolling in the rollover study and receiving study treatment. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
- •Women of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control throughout their participation and for 5 months following the last study treatment
排除标准
- •Subject was permanently discontinued from the parent study due to unacceptable toxicity, non-compliance with study procedures, withdrawal of consent, or any other reason.
- •Subject is receiving concurrent anti-cancer treatment (excluding combination drugs such as nivolumab or ipilimumab as a component of the combination dosing regimen used in parent study).
- •Women who are pregnant or breastfeeding.
- •Subject has any medical or social condition that, in the opinion of the Investigator, might place a subject at increased risk, affect compliance, or confound safety or other clinical study data interpretation.
研究组 & 干预措施
Vopratelimab
Participants will continue to receive vopratelimab monotherapy per parent protocol.
干预措施: Vopratelimab (Drug)
Vopratelimab with ipilimumab
Participants will continue to receive vopratelimab in combination with ipilimumab per parent protocol.
干预措施: Vopratelimab (Drug)
Vopratelimab with ipilimumab
Participants will continue to receive vopratelimab in combination with ipilimumab per parent protocol.
干预措施: Ipilimumab (Drug)
Vopratelimab with nivolumab
Participants will continue to receive vopratelimab in combination with nivolumab per parent protocol.
干预措施: Vopratelimab (Drug)
Vopratelimab with nivolumab
Participants will continue to receive vopratelimab in combination with nivolumab per parent protocol.
干预措施: Nivolumab (Drug)
结局指标
主要结局
Percentage of Subjects With Adverse Events (AEs)
时间窗: Approximately 34 months
Percentage of subjects with at least one AE
Percentage of Subjects With Serious Adverse Events (SAEs)
时间窗: Approximately 34 months
Percentage of subjects with at least one SAE
Percentage of Subjects With Clinically Significant Change From Baseline in Clinical Laboratory Tests
时间窗: Approximately 34 months
Percentage of subjects with at least one clinically significant change from baseline in clinical laboratory tests (i.e., change requiring adjustment of dose, clinical intervention or administration of concomitant medication)
次要结局
- Median Progression Free Survival (mPFS)(Approximately 34 months)