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Bladder Preservation for Muscle Invasive Bladder Cancer with Variant Histology

This study is for people with muscle-invasive bladder cancer (MIBC) that has a less common type of cell called variant histology. It is testing a treatment plan called trimodal therapy (TMT), which combines chemotherapy and radiation. Before TMT, participants will receive at least three cycles of neoadjuvant chemotherapy (NAC), which may or may not include immunotherapy (IO). The study wants to see if it's possible to start TMT within 45 days after NAC. To join, you must be at least 18 years old and have a confirmed diagnosis of MIBC with variant histology that has not spread beyond the bladder (cT2-T4N0M0). This study is currently unclear about its recruitment status and plans to enroll 20 participants.

Study design
This is a single-arm, open-label study, meaning all 20 participants will receive the same treatment, and both you and the study team will know what treatment you are getting.
What's involved
Participants will undergo at least 3 cycles of neoadjuvant chemotherapy (NAC) +/- immunotherapy (IO), followed by a four- or six-week course of concurrent standard of care chemotherapy and radiation therapy.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is to measure the feasibility of starting trimodal therapy (TMT) within 45 days after neoadjuvant chemotherapy (NAC).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06417190

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Leslie Ballas
~20 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Trimodal therapy (TMT) within 45 days of neoadjuvant chemotherapy (NAC)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of initiating TMT
Measured over 45 days

Conditions

Muscle-Invasive Bladder Carcinoma
Tumor

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Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cedars Sinai Medical Center

    Los Angeles, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Leslie Ballas, MD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center

Who to contact

Clinical Trial Navigator
[email protected]
310-423-5842
Email the study team

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Eligibility criteria

Inclusion

Documented diagnosis of MIBC with variant histology, cT2-T4N0M0, confirmed by TURBT and CT C/A/P and/or PET.
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion

Evidence of diffuse cis on pathology
Presence of bilateral hydronephrosis (if hydronephrosis is present, can only be unilateral)
Prior radiotherapy to the pelvis
History of systemic therapy for MIBS
Presence of concurrent cancer (remote history of cancer (\>5 years) allowed if the patient is without evidence of disease)

What this trial measures

  • Feasibility of initiating TMT45 days

    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