EUCTR2020-005452-38-GR进行中（未招募）1 期
A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA) - Volga
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 830
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Histologically or cytologically documented muscle-invasive UC of the
- •-Participants with transitional cell and mixed transitional/non
- •transitional cell histologies;
- •-Participants with MIBC clinical tumor (T) stage T2-T4aN0/1M0 or UC of the bladder with clinical state T1N1M0.
- •Participants should also have not received prior systemic chemotherapy
- •or immunotherapy for the treatment of MIBC or bladder UC.
- •Medically fit for cystectomy and able to receive neoadjuvant therapy;
- •ECOG performance status of 0, 1, 2 at enrollment.
- •Availability of tumor sample prior to study entry;
- •Must have a life expectancy of at least 12 weeks at randomization.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 380
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 450
排除标准
- •Evidence of lymph node (N2+) or metastatic TCC/UC disease at the time of screening.
- •Active infection
- •Uncontrolled intercurrent illness
- •Prior exposure to immune-mediated therapy (with exclusion of Bacillus-Calmette Guerin [BCG]), including but not limited to other anti-CTLA-4, anti-PD-1, anti PD-L1, or anti-PD-L2 antibodies.
- •Current or prior use of immunosuppressive medication within 14 days before the first dose of IPs.
研究者
相似试验
招募中
3 期
A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for Cisplatin or Who Refuse Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA)NL-OMON54296Astra Zeneca32
进行中（未招募）
1 期
Treatment combination of Durvalumab, Tremelimumab, Enfortumab Vedotin in patients with muscle invasive bladder cancer ineligible to cisplatiCisplatin ineligible patients with histologically or cytologically documented muscle-invasive transitional cell carcinoma (TCC) of the bladder.MedDRA version: 20.0Level: LLTClassification code 10005004Term: Bladder cancer NOSSystem Organ Class: 100000004864EUCTR2020-005452-38-ESAstraZeneca AB830
进行中（未招募）
1 期
Treatment combination of Durvalumab, Tremelimumab, Enfortumab Vedotin in patients with muscle invasive bladder cancer ineligible to cisplatin or Who Refuse CisplatiEUCTR2020-005452-38-NLAstraZeneca AB830
进行中（未招募）
1 期
Treatment combination of Durvalumab, Tremelimumab, Enfortumab Vedotin in patients with muscle invasive bladder cancer ineligible to cisplatin or Who Refuse CisplatiEUCTR2020-005452-38-ATAstraZeneca AB830
进行中（未招募）
1 期
Treatment combination of Durvalumab, Tremelimumab, EnfortumabVedotin in patients with muscle invasive bladder cancer ineligible tocisplatin or Who Refuse CisplatiEnglish Documented muscle-invasive urothelial carcinoma (UC) of the bladder in cisplatin ineligible patients or Who Refuse Cisplatin.MedDRA version: 20.0Level: LLTClassification code 10005004Term: Bladder cancer NOSSystem Organ Class: 100000004864EUCTR2020-005452-38-PLAstraZeneca AB830