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
Leslie Ballas
20 participants
Jan 16, 2026
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
Inclusion Criteria2
- 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 Criteria5
- 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)
Interventions
Single-arm, open-label
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06417190