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NCT04209114 · ClinicalTrials.gov registry record · Phase 3
A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer
A Phase 3 study of Bladder Cancer and Muscle-invasive Bladder Cancer, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 114
- Enrollment target
- 20
- Study locations
NCT04209114: Completed Phase 3 study of Bladder Cancer and Muscle-invasive Bladder Cancer, sponsored by Bristol-Myers Squibb.
NCT04209114 is a Phase 3 study of Bladder Cancer and Muscle-invasive Bladder Cancer that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 114 participants, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04209114, a Phase 3 study of Bladder Cancer and Muscle-invasive Bladder Cancer, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 114 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to see if treatment with nivolumab plus bempegaldesleukin or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with high-risk urothelial cancer, including muscle-invasive bladder cancer who are not able to receive cisplatin chemotherapy.
Primary Outcome
Pathologic Complete Response (pCR) is defined as the percentage of randomized participants with absence of any cancer in pathology specimens after radical cystectomy, based on blinded independent pathology review (BIPR). Participants who do not undertake surgery will be counted as non-pCR.
Conditions Studied
Interventions
- BIOLOGICAL Nivolumab
- PROCEDURE Radical cystectomy (RC)
- BIOLOGICAL Bempegaldesleukin
Study Locations (20)
Buenos Aires
- Local Institution - 0096 - Capital Federal
- Local Institution - 0028 - Ciudad Autónoma de Buenos Aires
- Local Institution - 0124 - La Plata
Arizona
- Local Institution - 0080 - Gilbert
- Local Institution - 0136 - Tucson
California
- Local Institution - 0029 - La Jolla
- Local Institution - 0015 - Orange
New York
- Local Institution - 0004 - Buffalo
- Local Institution - 0009 - The Bronx
Texas
- Local Institution - 0139 - Houston
- Local Institution - 0023 - Temple
Washington
- Local Institution - 0122 - Gig Harbor
- Local Institution - 0102 - Seattle
Iowa
- Local Institution - 0002 - Iowa City
Minnesota
- Local Institution - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2020-02-05 |
| Est. Completion | 2023-06-07 |
| Phase | Phase 3 |
What the finished NCT04209114 record still lists
NCT04209114 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT04209114 names 20 study sites across 13 states, led by Buenos Aires, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT04209114 about?
NCT04209114 is a clinical study titled "A Study of Nivolumab Plus Bempegaldesleukin (Bempeg/NKTR-214) vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That May Have Invaded The Muscle Wall of the Bladder and Who Cannot Get Cisplatin, A Type of Medicine Given To Treat Bladder Cancer". The purpose of the study is to see if treatment with nivolumab plus bempegaldesleukin or nivolumab alone, before and after surgery to remove the bladder, is more effective than surgery alone in participants with high-risk urothelial cancer, including muscle-invasive bladder cancer who are not able t...
What is the current status of trial NCT04209114?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 114 participants. The study started on 2020-02-05. Estimated completion is 2023-06-07.
What conditions does trial NCT04209114 study?
This clinical trial studies the following conditions: Bladder Cancer, Muscle-invasive Bladder Cancer, Bladder Tumor.
What interventions are being tested in trial NCT04209114?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Radical cystectomy (RC) (PROCEDURE), Bempegaldesleukin (BIOLOGICAL).
Who is sponsoring clinical trial NCT04209114?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04209114 being conducted?
This trial has 20 study locations across Arizona, California, Iowa, Minnesota, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bladder Cancer
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 NCT04209114's enrollment target sits among peer trials
114 81st of 175 higher than 95 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection
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A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
ACTIVE NOT RECRUITING · Phase 3
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A Phase 3 Study of UGN-103 for Treatment of Patients With Low-grade Intermediate-risk Non-muscle Invasive Bladder Cancer
ACTIVE NOT RECRUITING · Phase 3
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