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NCT06417190 · ClinicalTrials.gov registry record · Phase 2
Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology
A Phase 2 study of Tumor and Muscle-Invasive Bladder Carcinoma, sponsored by Leslie Ballas.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06417190 is a Phase 2 study of Tumor and Muscle-Invasive Bladder Carcinoma that is actively recruiting participants, run by Leslie Ballas. The registered enrollment target is 20 participants, below the 184-participant average among 18 other Tumor trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06417190, a Phase 2 study of Tumor and Muscle-Invasive Bladder Carcinoma, is actively recruiting participants, sponsored by Leslie Ballas.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase II, single cohort study designed to evaluate outcomes in patients with muscle invasive bladder cancer (MIBC) with variant histology who receive neoadjuvant chemotherapy (NAC) with or without immunotherapy (IO) followed by trimodal therapy (TMT). Enrolled patients will undergo at least 3 cycles of NAC +/- IO (oncologist's choice) followed by a four- or six-week course of concurrent standard of care chemotherapy and radiation therapy. These patients will be compared with historical controls of patients with a diagnosis of pure urothelial carcinoma who have undergone TMT. This study has been designed to test the hypothesis that variant histology TMT can be delivered within 45 days of NAC +/- IO and is therefore a viable option in patients who are risk of systemic disease spread.
Conditions Studied
Interventions
- DRUG Trimodal therapy (TMT) within 45 days of neoadjuvant chemotherapy (NAC)
Study Locations (1)
California
- Cedars Sinai Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2026-01-16 |
| Est. Completion | 2030-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06417190
The ClinicalTrials.gov registry entry for NCT06417190 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 184-participant average among 18 other Tumor trials with a reported enrollment target (89% lower). The listed sponsor is Leslie Ballas, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Tumor appearing as the primary indexed condition, and to 1 intervention - of which Trimodal therapy (TMT) within 45 days of neoadjuvant chemotherapy (NAC) is the first listed.
NCT06417190 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06417190 about?
NCT06417190 is a clinical study titled "Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology". This is a Phase II, single cohort study designed to evaluate outcomes in patients with muscle invasive bladder cancer (MIBC) with variant histology who receive neoadjuvant chemotherapy (NAC) with or without immunotherapy (IO) followed by trimodal therapy (TMT). Enrolled patients will undergo at leas...
What is the current status of trial NCT06417190?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2026-01-16. Estimated completion is 2030-12.
What conditions does trial NCT06417190 study?
This clinical trial studies the following conditions: Tumor, Muscle-Invasive Bladder Carcinoma.
What interventions are being tested in trial NCT06417190?
The interventions under investigation include: Trimodal therapy (TMT) within 45 days of neoadjuvant chemotherapy (NAC) (DRUG).
Who is sponsoring clinical trial NCT06417190?
This trial is sponsored by Leslie Ballas, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06417190 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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