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)

  • STATUS
    Recruiting
  • End date
    Sep 8, 2028
  • participants needed
    830
  • sponsor
    AstraZeneca
Updated on 20 September 2022

Summary

A global phase 3, multicenter, randomized, trial, 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 Cisplantin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer.

The goal of the study is to explore the triplet combination of Durvalumab, Tremelimumab and Enfortumab Vedotin in terms of efficacy and safety compared to the current Standard Of Care (SOC).

Volga trial consists of two parts: Safety Run-In and Main Study. In total the study aims to enroll approximately 830 patients, who will receive triplet combination, duplet combination of Durvalumab and Enfortumab vedotin or currently approved SOC in the main trial. In the main part of the trial there is two out of three chances of being on a treatment arm and the treatment is assigned at random by a computer system.

In this trial patients in the two treatment arms will receive either 3 cycles of neoadjuvant Durvalumab + Tremelimumab + Enfortumab Vedotin or Durvalumab + Enfortumab vedotin and after surgery both treatment arms will continue with adjuvant Durvalumab.

Description

Not provided

Details
Condition Muscle Invasive Bladder Cancer
Treatment tremelimumab, Nivolumab, durvalumab, Enfortumab vedotin, Radical Cystectomy
Clinical Study IdentifierNCT04960709
SponsorAstraZeneca
Last Modified on20 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically or cytologically documented muscle-invasive UC of the bladder
Medically fit for cystectomy and able to receive neoadjuvant therapy
Participants with transitional cell and mixed transitional/non-transitional cell histologies
Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC
Participants with MIBC clinical tumor (T) stage T2-T4aN0/1M0 or UC of the bladder with clinical state T1N1M0
ECOG performance status of 0,1,2 at enrollment
Participants should also have not received prior systemic chemotherapy or immunotherapy for the treatment of MIBC or bladder UC
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 (must be documented in the medical records)

Exclusion Criteria

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
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