Home › Cancer (all types) › NCT06417190

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

Who can join

Ages 18 and older · All sexes

Inclusion Criteria:

* 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 Criteria:

* 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)

About the study

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.

What is being tested

• Trimodal therapy (TMT) within 45 days of neoadjuvant chemotherapy (NAC) (drug)

Sponsor: Leslie Ballas · Participants: 20 · Started: Jan 16, 2026

Contact the study team

• Clinical Trial Navigator · Phone: 310-423-5842

Official record on ClinicalTrials.gov — NCT06417190

Locations in the U.S.

Conditions

• Cancer (all types)

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.