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

ClinicalTrials.gov ID: NCT04960709

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.

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ClinicalTrials.gov public records Last synced Oct 19, 2026, 1:14 PM EDT

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
Lead sponsor: AstraZeneca; Industry
Enrollment: 712 participants

Conditions and interventions

Conditions

Muscle Invasive Bladder Cancer

Interventions

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 5, 2021 (Actual)
Primary completion: Mar 2, 2026 (Actual)
Completion: Sep 8, 2028 (Estimated)
Last update posted: Jun 4, 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 4, 2026 · Synced Oct 19, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04960709 live on ClinicalTrials.gov.

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