NCT06417190RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 6 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 13 May 2024
- Start date
- 16 Jan 2026
- Primary completion date
- Dec 2030
- Lead sponsor
- Leslie Ballas
- Diseases
- Bladder cancer
- NCT number
- NCT06417190
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 16 Jan 2026 to the primary completion date, Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior radiotherapy to the pelvis
Other illness
- History of systemic therapy for MIBS
Age
- Presence of concurrent cancer (remote history of cancer (\>5 years) allowed if the patient is without evidence of disease)
Other
- Evidence of diffuse cis on pathology
- Presence of bilateral hydronephrosis (if hydronephrosis is present, can only be unilateral)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.