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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: Active Phase 3 study of Muscle-invasive Bladder Cancer, sponsored by AstraZeneca.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Frequency of Adverse Events.
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 |
What the registry record for NCT04960709 still lists
NCT04960709 is an interventional study that assigns participants to a tested intervention. The registered 712 participants enrollment target is mid-sized for trials with a published cap, below the 1,265-participant average among 10 other Muscle-invasive Bladder Cancer trials with a reported enrollment target (44% lower).
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 names 20 study sites across 16 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04960709's enrollment target sits among peer trials
712 5th of 10 higher than 6 of 10 other Muscle-invasive Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Muscle-invasive Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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