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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment20 people
  • Recruiting US sites1
  • SponsorLeslie Ballas
  • RegistryNCT06417190

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology: a one-minute explainerNCT064171901 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • 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.

You cannot join if

  • 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)

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

  • Trimodal therapy (TMT) within 45 days of neoadjuvant chemotherapy (NAC) (Drug): Single-arm, open-label

The study

Treatment groups

Na · Single Group · masking: None

Single Arm (Experimental)

Neoadjuvant chemotherapy followed by trimodal therapy consisting of TURBT followed by concurrent chemotherapy with radiation therapy

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • radiation: Part of the study plan

Goals

What the study measures

Main goals

  • Feasibility of initiating TMT (45 days)

Other goals

  • 3-year bladder intact event free survival (BIEFS)

Planned enrollment: 20 (estimated).

Where

Recruiting US sites

  • Cedars Sinai Medical Center, Los Angeles, California

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 5, 2026. Public record; not medical advice.

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