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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: Recruiting Phase 2 study of Tumor and Muscle-Invasive Bladder Carcinoma, sponsored by Leslie Ballas.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate the feasibility of initiating TMT within 45 days of completion of NAC - Feasibility will be defined as at least 17 study participants initiating TMT within 45 days of NAC
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 |
What NCT06417190 shows while recruiting
NCT06417190 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 184-participant average among 18 other Tumor trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06417190's enrollment target sits among peer trials
20 18th of 18 higher than 1 of 18 other Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tumor 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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