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

NCT06417190 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IIT2023-13-BALLAS-VHTMT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Tumor; Muscle-Invasive Bladder Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Feasibility of initiating TMT

  To evaluate the feasibility of initiating TMT within 45 days of completion of NAC - Feasibility will be defined as at least 17 study participants initiating TMT within 45 days of NAC

  45 days

Secondary Outcomes (1)

• 3-year bladder intact event free survival (BIEFS)

  3 year

Other Outcomes (4)

• Progression free (<=T2) survival rates

  3 year

• Metastasis-free survival

  3 year

• Rate of salvage cystectomy

  3 year

Study Arms (1)

Single Arm

EXPERIMENTAL

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

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

Interventions

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

Single-arm, open-label

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Leslie Ballas: lead

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Trail Making Test; Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Combined Modality Therapy; Therapeutics

Study Officials

• Leslie Ballas, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trial Navigator

CONTACT

3104232133; GroupCancerTrialInformation@cshs.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Model Details: Single-arm, open-label

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 16, 2024
• Study Start: January 16, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)