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

RecruitingPhase 2Ages 18 Years - anyAllLeslie Ballas
NCT06417190 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

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

1 site
Cedars Sinai Medical Center
Los Angeles, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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