Recruiting
Phase 2

Bladder Preservation

Sponsor:

Leslie Ballas

Code:

NCT06417190

Conditions

Muscle-Invasive Bladder Carcinoma

Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Muscle-Invasive Bladder Carcinoma

Tumor

Study ID

NCT06417190

Start date

Jan 16, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single Arm

Neoadjuvant chemotherapy followed by trimodal therapy consisting of TURBT followed by concurrent chemotherapy with radiation therapy

Interventions

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

Single-arm, open-label

Primary outcome measure

  • Feasibility of initiating TMT [ Time Frame: 45 days ]

Central Contacts and Locations

Central contacts

Clinical Trial Navigator

310-423-5842GroupCancerTrialInformation@cshs.org

Locations

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Clinical Trial Recruitment Navigator

310-423-5842GroupCancerTrialInformation@cshs.org

Principal Investigator:

Leslie Ballas, MD

More Information

Sponsor

Leslie Ballas

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • Trimodal Therapy (TMT)
  • Neoadjuvant Chemotherapy
  • muscle-invasive urothelial cell bladder cancer (MIBC)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Leslie Ballas on 2026-08-06.