Volga
Research type
Research Study
Full title
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)
IRAS ID
298169
Contact name
Thomas Powles
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2020-005452-38
Clinicaltrials.gov Identifier
125017, IND number
Duration of Study in the UK
8 years, 0 months, 0 days
Research summary
The aim of this study is to learn more about if the combination of medications called durvalumab, tremelimumab and enfortumab vedotin (EV) before and after surgery will work and be safe for the treatment of muscle invasive bladder cancer, and also to better understand the studied disease and associated health problems.
Participants in the UK will be enrolled into the main study into 1 of 3 treatment options, known as arms 1, 2 and 3. Prior to surgery – Arm 1: Durvalumab,Tremelimumab and Enfortumab Vedotin; Arm 2: Durvalumab and Enfortumab Vedotin; Arm 3: directly to surgery.
All participants will undergo a surgical procedure called a Radical Cystectomy in which the bladder is removed. This type of surgery is commonly performed in the UK for patients with invasive bladder cancer.
After surgery participants in Arm 1 will receive Durvalumab and Tremelimumab, Arm 2 will receive Durvalumab and Arm 3 will be observed.
While durvalumab and enfortumab vedotin are approved for use in tumours in certain circumstances, this study is experimental and these drugs are not approved for use in this setting except for use in research studies like this.
This study involves a screening period, treatment period and a follow-up period which involve about 25 or more visits to the clinic. Participants will be in the study for up to 5 years – approximately one year of treatment and up to 4 years of follow up. During the treatment period the study drugs will be administered by IV (intravenously-via infusion in a vein over a period of time). Whilst on the study participants will undergo a number of tests and procedures which include taking blood and urine samples, electrocardiography (heart monitoring) and completing questionnaires.
Approximately 810 patients will take part in the main study in hospitals in over 20 countries globally.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
21/EM/0159
Date of REC Opinion
18 Aug 2021
REC opinion
Further Information Favourable Opinion