NCT06417190 Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology
| NCT ID | NCT06417190 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Leslie Ballas |
| Condition | Muscle-Invasive Bladder Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-01-16 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2026-01-16 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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)
Contact & Investigator
Leslie Ballas, MD
PRINCIPAL INVESTIGATOR
Cedars-Sinai Medical Center
Frequently Asked Questions
Who can join the NCT06417190 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Muscle-Invasive Bladder Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06417190 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06417190 currently recruiting?
Yes, NCT06417190 is actively recruiting participants. Contact the research team at GroupCancerTrialInformation@cshs.org for enrollment information.
Where is the NCT06417190 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06417190 clinical trial?
NCT06417190 is sponsored by Leslie Ballas. The principal investigator is Leslie Ballas, MD at Cedars-Sinai Medical Center. The trial plans to enroll 20 participants.