RecruitingPhase 2NCT06417190

Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology

IIT2023-13-BALLAS-VHTMT: Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology


Sponsor

Leslie Ballas

Enrollment

20 participants

Start Date

Jan 16, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring bladder preservation (keeping the bladder instead of removing it) as a treatment option for people with muscle-invasive bladder cancer that has an unusual or mixed cell type (called variant histology). This approach combines radiation, chemotherapy, and other treatments to try to destroy the cancer without surgery. **You may be eligible if...** - You have been diagnosed with muscle-invasive bladder cancer with a variant (uncommon) cell type - Your cancer is confirmed to be localized (stages T2–T4, no distant spread), confirmed by biopsy and imaging scans - You are willing and able to consent and follow the study procedures **You may NOT be eligible if...** - There is widespread superficial cancer spread (diffuse CIS) in your bladder - You have blockage in both kidneys (bilateral hydronephrosis) - You have previously received pelvic radiation - You have previously received systemic therapy for bladder cancer - You currently have another active cancer (past cancer more than 5 years ago is generally acceptable) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrimodal therapy (TMT) within 45 days of neoadjuvant chemotherapy (NAC)

Single-arm, open-label


Locations(1)

Cedars Sinai Medical Center

Los Angeles, California, United States

View Full Details on ClinicalTrials.gov

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NCT06417190


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