NCT07762586 Luminal Bladder Cancer Effective Response to Neoadjuvant Chemotherapy (LUMBER-NAC)
| NCT ID | NCT07762586 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-07-10 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2026-07-10 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * ▪ Inclusion Criteria * 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. Exclusion Criteria: * 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.
Contact & Investigator
Saum Ghodoussipour, MD
PRINCIPAL INVESTIGATOR
Rutgers University
Frequently Asked Questions
Who can join the NCT07762586 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07762586 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07762586 currently recruiting?
Yes, NCT07762586 is actively recruiting participants. Contact the research team at sg1621@cinj.rutgers.edu for enrollment information.
Where is the NCT07762586 trial being conducted?
This trial is being conducted at New Brunswick, United States.
Who is sponsoring the NCT07762586 clinical trial?
NCT07762586 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Saum Ghodoussipour, MD at Rutgers University. The trial plans to enroll 60 participants.
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