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NCT04960709 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Muscle-invasive Bladder Cancer, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 712
- Enrollment target
- 20
- Study locations
NCT04960709 is a Phase 3 study of Muscle-invasive Bladder Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 712 participants, below the 1,265-participant average among 10 other Muscle-invasive Bladder Cancer trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 16 states.
The verdict
NCT04960709, a Phase 3 study of Muscle-invasive Bladder Cancer, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 712 participants
- Enrollment target
- 20
- Study locations
Study 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 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.
Conditions Studied
Interventions
- DRUG Enfortumab Vedotin
- DRUG Durvalumab
- DRUG Tremelimumab
- PROCEDURE Radical Cystectomy
Study Locations (20)
New York
- Research Site - Brooklyn
- Research Site - Buffalo
- Research Site - New York
- Research Site - Syracuse
California
- Research Site - Orange
- Research Site - Santa Monica
Connecticut
- Research Site - New Haven
District of Columbia
- Research Site - Washington D.C.
Florida
- Research Site - Fort Myers
Idaho
- Research Site - Coeur d'Alene
Illinois
- Research Site - Maywood
Indiana
- Research Site - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 712 participants |
| Start Date | 2021-08-05 |
| Est. Completion | 2028-09-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04960709
The ClinicalTrials.gov registry entry for NCT04960709 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 712 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,265-participant average among 10 other Muscle-invasive Bladder Cancer trials with a reported enrollment target (44% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Muscle-invasive Bladder Cancer appearing as the primary indexed condition, and to 4 interventions - of which Enfortumab Vedotin is the first listed.
NCT04960709 reports 20 study locations spanning 16 distinct geographic areas - top geographies include New York, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT04960709 about?
NCT04960709 is a clinical study titled "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". 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 b...
What is the current status of trial NCT04960709?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 712 participants. The study started on 2021-08-05. Estimated completion is 2028-09-08.
What conditions does trial NCT04960709 study?
This clinical trial studies the following conditions: Muscle-invasive Bladder Cancer.
What interventions are being tested in trial NCT04960709?
The interventions under investigation include: Enfortumab Vedotin (DRUG), Durvalumab (DRUG), Tremelimumab (DRUG), Radical Cystectomy (PROCEDURE).
Who is sponsoring clinical trial NCT04960709?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04960709 being conducted?
This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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