Treatment Combination of Durvalumab, Tremelimumab and Enfortumab Vedotin or Durvalumab and Enfortumab Vedotin in Patients With Muscle Invasive Bladder Cancer Ineligible to Cisplatin or Who Refuse Cisplatin
Public ClinicalTrials.gov record NCT04960709. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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 or Who Refuse Cisplatin Undergoing Radical Cystectomy for Muscle Invasive Bladder Cancer (VOLGA)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 Cisplatin based chemotherapy 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 or the duplet combination of Durvalumab 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 677 patients, who will receive triplet combination, duplet combination or currently approved SOC in the main study. 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 + Enfortumab Vedotin and 2 cycles of Tremelimumab or Durvalumab + Enfortumab vedotin and after surgery both treatment arms will receive either adjuvant Durvalumab or adjuvant Durvalumab and 1 cycle of Tremelimumab.
Study identification
- NCT ID
- NCT04960709
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 712 participants
Conditions and interventions
Conditions
Interventions
- Durvalumab Drug
- Tremelimumab Drug
- Enfortumab Vedotin Drug
- Radical Cystectomy Procedure
Drug · Procedure
Eligibility (public fields only)
- Age range
- 18 Years to 130 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 4, 2021
- Primary completion
- Mar 1, 2026
- Completion
- Sep 7, 2028
- Last update posted
- Jun 3, 2026
2021 – 2028
United States locations
- U.S. sites
- 31
- U.S. states
- 22
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Orange | California | 92868 | — |
| Research Site | Santa Monica | California | 90404 | — |
| Research Site | New Haven | Connecticut | 06510 | — |
| Research Site | Washington D.C. | District of Columbia | 20010 | — |
| Research Site | Fort Myers | Florida | 33901 | — |
| Research Site | Coeur d'Alene | Idaho | 83814 | — |
| Research Site | Maywood | Illinois | 60153 | — |
| Research Site | Indianapolis | Indiana | 46250 | — |
| Research Site | Iowa City | Iowa | 52242 | — |
| Research Site | Louisville | Kentucky | 40207 | — |
| Research Site | Scarborough | Maine | 04074 | — |
| Research Site | Boston | Massachusetts | 02111 | — |
| Research Site | Brighton | Michigan | 48114 | — |
| Research Site | Jackson | Mississippi | 39213 | — |
| Research Site | Las Vegas | Nevada | 89102 | — |
| Research Site | Saddle Brook | New Jersey | 07663 | — |
| Research Site | Brooklyn | New York | 11219 | — |
| Research Site | Buffalo | New York | 14263 | — |
| Research Site | New York | New York | 10040 | — |
| Research Site | Syracuse | New York | 13210 | — |
| Research Site | Portland | Oregon | 97239 | — |
| Research Site | Hershey | Pennsylvania | 17033 | — |
| Research Site | Pittsburgh | Pennsylvania | 15212 | — |
| Research Site | Knoxville | Tennessee | 37932 | — |
| Research Site | Austin | Texas | 78731 | — |
| Research Site | Dallas | Texas | 75246 | — |
| Research Site | Fort Worth | Texas | 76104 | — |
| Research Site | Houston | Texas | 77030 | — |
| Research Site | Irving | Texas | 75063 | — |
| Research Site | Norfolk | Virginia | 23502 | — |
| Research Site | Spokane | Washington | 99208 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 165 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04960709, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 3, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04960709 live on ClinicalTrials.gov.