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) - Volga

AstraZeneca AB0 个研究点目标入组 830 人开始时间: 2021年6月29日最近更新: 2024年4月8日

试验速览

暂无简介。

•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.
•-Cisplatin-ineligible, as defined by any of the following criteria (based on Galsky et al 2011) OR Refuse cisplatin based chemotherapy.
•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

•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.

发起方