Luminal Bladder Cancer Effective Response to Neoadjuvant Chemotherapy (LUMBER-NAC)

NCT07762586 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 082505
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a two-arm phase II randomized trial investigating patients with luminal subtype muscle-invasive bladder cancer (MIBC) receiving neoadjuvant therapy (NAT) followed by cystectomy compared to those receiving upfront cystectomy.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• : Pathological upstaging rate at radical cystectomy (pT3-pT4 or pN+)

  Percentage of evaluable participants in each study arm who are pathologically upstaged from clinical stage cT2N0 disease to pathological stage pT3-pT4 or pN+ disease, based on examination of the radical cystectomy specimen.

  At the time of radical cystectomy

Secondary Outcomes (1)

• Change From Baseline in Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) Bladder Cancer Subscale (BlCS) Score

  Baseline and 1, 3, and 6 months after radical cystectomy

Study Arms (2)

Neoadjuvant Systemic Therapy Followed by Radical Cystectomy

ACTIVE COMPARATOR

Participants receive standard-of-care neoadjuvant systemic therapy, as selected by the treating physician, followed by radical cystectomy with urinary diversion. Interventions: Each specific drug regimen confirmed by the PI, plus Radical Cystectomy With Urinary Diversion.

Drug: Neoadjuvant Therapy; Procedure: Upfront radical cystectomy

Upfront Radical Cystectomy

EXPERIMENTAL

Participants proceed directly to radical cystectomy with urinary diversion without receiving initial neoadjuvant systemic therapy. Intervention: Radical Cystectomy With Urinary Diversion

Procedure: Upfront radical cystectomy

Interventions

Neoadjuvant Therapy DRUG

Patients will undergo standard of care neoadjuvant therapy followed by radical cystectomy

Neoadjuvant Systemic Therapy Followed by Radical Cystectomy

Upfront radical cystectomy PROCEDURE

Patients will undergo upfront radical cystectomy without neoadjuvant therapy

Neoadjuvant Systemic Therapy Followed by Radical Cystectomy; Upfront Radical Cystectomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide informed consent
• Age ≥18 years old
• Eligible to receive standard of care systemic neoadjuvant therapy
• Eastern Cooperative Group (ECOG) performance status of 0-1
• Documented histologically confirmed urothelial muscle-invasive bladder cancer
• cT2N0M0 bladder cancer based on pre-TURBT bimanual exam and cross-sectional imaging performed within 8 weeks of surgery or initiation of NAT.
• Willing to undergo RC with urinary diversion
• No signs of extravesical disease on pre-TURBT conventional imaging
• Variant histology is allowed so long as the tumor is predominantly urothelial carcinoma.
• No presence of LVI on TURBT
• Decipher Bladder GSC test result
• Ineligible for or refusing TMT
• No cN+
• The population is adult men or women of any ethnicity diagnosed with muscle-invasive bladder cancer.

You may not qualify if:

• Patients under 18 years old. Considering the minimal incidence of bladder cancer among the pediatric population, children are not eligible for this study.
• Not willing or unable to give informed consent.
• Clinical or pathological evidence of metastatic disease, including, non-regional lymph nodes, visceral lesions, and bone lesions.
• Significant hepatic impairment (Serum bilirubin \> 1.5x upper limit of normal).
• Significant renal impairment (creatinine clearance \<30 ml/min).
• Predominant variant histology (i.e. nested, micropapillary, sarcomatoid, plasmacytoid, small cell)6
• cT3 bladder cancer on pre-TURBT bimanual exam or with hydronephrosis on cross-sectional imaging performed within 8 weeks of surgery or initiation of NAT
• TURBT specimen with lymphovascular invasion (LVI) cT4 or unresectable bladder cancer
• Concurrent diagnoses of other, non-urothelial, malignancies or prior malignancy diagnoses within the past three years. Exceptions, determined at the discretion of the principal investigator, include squamous cell carcinoma, basal cell carcinoma, or other low-grade cancer not expected to progress or require surgical/systemic therapy.
• Prior history of systemic treatment for non-urothelial malignancies in the past three years, including chemotherapy and immunotherapy.
• Prior diagnosis or evidence of psychiatric or medical conditions that may prevent patients from giving full and properly informed consent.
• Any medical, familial, psychiatric, or geographic considerations that may prevent patients from study participation or follow-up required by the study protocol
• Patients (cN+) are excluded from participation and are not eligible for enrollment.
• Prisoners, Individuals without Decisional Capacity, and Pregnant Women will be excluded.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers Cancer Institute

New Brunswick, New Jersey, 08901, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Saum Ghodoussipour, MD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saum Ghodoussipour, MD

CONTACT

732-235-2465; sg1621@cinj.rutgers.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Bladder and Urothelial Cancer Program, Rutgers Cancer Institute

Model Details: This study is a two- arm phase II randomized trial investigating patients with luminal subtype muscle invasive bladder cancer (MIBC) receiving neoadjuvant therapy (NAT) followed by cystectomy compared to those receiving upfront cystectomy.

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: August 13, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2029
• Last Updated: August 13, 2026

Record last verified: 2026-08

Locations

US (1)