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NCT04289779 · ClinicalTrials.gov registry record · Phase 2
Study of CAbozantinib in Combination with AtezolizumaB for Muscle-Invasive BladdEr Cancer
A Phase 2 study of Bladder Cancer, sponsored by Deepak Kilari.
- Active
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 6
- Study locations
NCT04289779: Active Phase 2 study of Bladder Cancer, sponsored by Deepak Kilari.
NCT04289779 is a Phase 2 study of Bladder Cancer that is active but no longer recruiting, run by Deepak Kilari. The registered enrollment target is 46 participants, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04289779, a Phase 2 study of Bladder Cancer, is active but no longer recruiting, sponsored by Deepak Kilari.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is an open-label phase II study assessing the activity of cabozantinib combined with atezolizumab in patients with resectable muscle-invasive urothelial carcinoma who are ineligible for cisplatin-based therapy or decline cisplatin-based therapy. Each cycle equals 21 days. The dose of atezolizumab is 1200 mg IV flat dose every 3 weeks (Day 1) plus cabozantinib 40 mg orally daily (Day 1 through Day 21). Patients will receive three cycles of treatment prior to cystectomy unless they discontinue treatment for unacceptable toxicity or progressive disease by RECIST v1.1 or withdraw consent.
Primary Outcome
Estimate the pathologic response (PaR) rate to neoadjuvant cabozantinib and atezolizumab in subjects with muscle-invasive urothelial cancer of the bladder. Pathologic response rate (PaR) is defined as the absence of residual muscle-invasive cancer in the surgical specimen (pathologic downstaging to ≤ pT1pN0), which includes pT0, pT1, pTa, and pTis
Conditions Studied
Interventions
- DRUG Atezolizumab
- DRUG Cabozantinib
- PROCEDURE Cystectomy
Study Locations (6)
Missouri
- Washington University School of Medicine - St Louis
New Jersey
- John Theurer Cancer Center - Hackensack
New York
- University of Rochester Medical Center - Rochester
Tennessee
- Vanderbilt-Ingram Cancer Center - Nashville
Virginia
- Virginia Commonwealth University - Richmond
Wisconsin
- Froedtert and The Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2020-05-21 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What the registry record for NCT04289779 still lists
NCT04289779 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Bladder Cancer appearing as the primary indexed condition, and to 3 interventions - of which Atezolizumab is the first listed.
NCT04289779 lists 6 locations in 6 states (Missouri, New Jersey, New York).
Frequently Asked Questions
What is clinical trial NCT04289779 about?
NCT04289779 is a clinical study titled "Study of CAbozantinib in Combination with AtezolizumaB for Muscle-Invasive BladdEr Cancer". This is an open-label phase II study assessing the activity of cabozantinib combined with atezolizumab in patients with resectable muscle-invasive urothelial carcinoma who are ineligible for cisplatin-based therapy or decline cisplatin-based therapy. Each cycle equals 21 days. The dose of atezolizum...
What is the current status of trial NCT04289779?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2020-05-21. Estimated completion is 2025-12.
What conditions does trial NCT04289779 study?
This clinical trial studies the following conditions: Bladder Cancer.
What interventions are being tested in trial NCT04289779?
The interventions under investigation include: Atezolizumab (DRUG), Cabozantinib (DRUG), Cystectomy (PROCEDURE).
Who is sponsoring clinical trial NCT04289779?
This trial is sponsored by Deepak Kilari, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04289779 being conducted?
This trial has 6 study locations across Missouri, New Jersey, New York, Tennessee, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04289779's enrollment target sits among peer trials
46 121st of 175 higher than 53 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.
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