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NCT Number: NCT06417190

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

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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Key information

Conditions

Muscle-Invasive Bladder Carcinoma Neoplasms Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Anirban Mitra, MD, PhD

SUB_INVESTIGATOR

Charles Rosser, MD

SUB_INVESTIGATOR

Clinical Trial Recruitment Navigator

CONTACT

[email protected]

3104232133

Leslie Ballas, MD

PRINCIPAL_INVESTIGATOR

Michael Ahdoor, MD

SUB_INVESTIGATOR

About this study

Trimodal therapy (TMT) is accepted as an NCCN category 1 alternative to radical cystectomy (with neoadjuvant chemotherapy) in patients with cT2N0M0 muscle-invasive urothelial cell bladder cancer (MIBC). Not all patients with MIBC have pure urothelial cell carcinoma; urothelial carcinoma with variant histology (VH) described any morphologic variant of conventional urothelial carcinoma that is believed to be derived from urothelial carcinoma and is typically admixed with conventional urothelial carcinoma in the same tumor. Variant histologies described include squamous differentiation, glandular differentiation, micropapillary, sarcomatoid, small cell/neuroendocrine, plasmacytoid and nested variant. This is a rare tumor type and understudied. For patients with variant histologies there is limited data on the use of trimodal therapy. There are a couple single institution retrospective studies and data from the NCDB, but no prospective data.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Drug

Single-arm, open-label

Primary outcomes

  1. Feasibility of initiating TMT

    Time frame: 45 days

    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

Secondary outcomes

  1. 3-year bladder intact event free survival (BIEFS)

    Time frame: 3 year

    To estimate 3-year bladder intact event free survival (BIEFS) in patients undergoing TMT for MIBC with VH-TMT

Other outcomes

  1. Progression free (<=T2) survival rates

    Time frame: 3 year

    To estimate progression free (<=T2) survival rates from TMT

  2. Metastasis-free survival

    Time frame: 3 year

    To estimate the metastasis-free survival of TMT

  3. Rate of salvage cystectomy

    Time frame: 3 year

    To estimate the rate of salvage cystectomy following TMT

  4. Blood and urine correlatives of clinical outcomes

    Time frame: 3 year

    To investigate blood and urine correlatives of clinical outcomes (Signatera and Oncuria)

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trial Navigator

CONTACT

[email protected]

3104232133

Sponsors and collaborators

Lead sponsor

Leslie Ballas

Other

Registry information

Official study title

IIT2023-13-BALLAS-VHTMT: Bladder Preservation for Patients With Muscle Invasive Bladder Cancer (MIBC) With Variant Histology

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
May 16, 2024
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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