J4G-MC-JZVD - FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined with Enfortumab Vedotin and Pembrolizumab in Adults with Untreated Locally Advanced or Metastatic Urothelial Carcinoma with an FGFR3 Genetic Alteration.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 197
- 试验地点
- 137
- 主要终点
- Safety Lead-in:Safety and Tolerability of vepugratinib in combination with EV and pembrolizumab
研究概览
简要总结
The purpose of this study is to test a new medicine, vepugratinib, in comparison with placebo, to see if it is safe and can help people with a bladder cancer that is advanced or has spread. Vepugratinib or placebo will be administered in combination with enfortumab vedotin and pembrolizumab. Study participation could last up to approximately 6 years.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •A type of cancer called urothelial cancer that has spread to other parts of your body and cannot be removed with surgery
- •A specific genetic change in the FGFR3 gene that can be found in a tumor or blood sample
- •Tumors that can be measured by a doctor using a special system called RECIST v1.1
- •Moderate to good level of physical ability
- •Adequate laboratory test results
排除标准
- •Have already had treatment for cancer that has spread to other parts of your body
- •Still have side effects from previous cancer treatment that are worse than mild
- •Have nerve damage that affects your senses or movement
- •Have cancer that has spread to the brain that is untreated or uncontrolled
- •Have eye problems like corneal keratopathy or retinal disorder that are symptomatic or haven't been treated yet
研究组 & 干预措施
PEMBROLIZUMAB
干预措施: PEMBROLIZUMAB (Drug)
ENFORTUMAB VEDOTIN
干预措施: ENFORTUMAB VEDOTIN (Drug)
null, null, null
干预措施: null, null, null (Drug)
Placebo to match ly
干预措施: Placebo to match ly (Drug)
结局指标
主要结局
Safety Lead-in:Safety and Tolerability of vepugratinib in combination with EV and pembrolizumab
Safety Lead-in:Safety and Tolerability of vepugratinib in combination with EV and pembrolizumab
Safety Lead-in:Overall Response Rate (ORR)
Safety Lead-in:Overall Response Rate (ORR)
Progression-free Survival (PFS) by Blinded Independent Central Review (BICR)
Progression-free Survival (PFS) by Blinded Independent Central Review (BICR)
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.