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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Leslie Ballas
Study ID
NCT06417190
Phase
PHASE2
Status
Recruiting
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Conditions

  • Muscle-Invasive Bladder Carcinoma
  • Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trimodal therapy (TMT) within 45 days of neoadjuvant chemotherapy (NAC) — DRUG
    Single-arm, open-label

Study Details

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.

Key Dates

Start date
Jan 16, 2026
Status verified
May 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm
    Neoadjuvant chemotherapy followed by trimodal therapy consisting of TURBT followed by concurrent chemotherapy with radiation therapy

Primary Outcome Measure

Feasibility of initiating TMT [ Time Frame: 45 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048
Clinical Trial Recruitment Navigator
[email protected]
3104232133
Leslie Ballas, MD (PRINCIPAL_INVESTIGATOR)
Anirban Mitra, MD, PhD (SUB_INVESTIGATOR)
Michael Ahdoor, MD (SUB_INVESTIGATOR)
Charles Rosser, MD (SUB_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Cedars Sinai Medical Center· Los Angeles, CA

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