Bladder CancerPhase 2NCT07762586
Luminal Bladder Cancer Effective Response to Neoadjuvant Chemotherapy (LUMBER-NAC)
A Phase 2 study testing Neoadjuvant Therapy and Upfront radical cystectomy in people with Bladder Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Neoadjuvant Therapy and Upfront radical cystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2026to Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ▪ 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rutgers Cancer Institute
New Brunswick, New Jersey, 08901
Saum Ghodoussipour, MD, 732-235-5265, sg1621@cinj.rutgers.edu
About this study
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.
Read the detailed description
The goal of this study is to assess the feasibility and oncologic safety of upfront radical cystectomy in luminal MIBC, using pathological upstaging (pT3-4 or pN+) and efficacy as the primary safety endpoints.
For patients with muscle-invasive bladder cancer (MIBC), the standard treatment remains sequential neoadjuvant therapy (NAT), which may include either cisplatin-based chemotherapy or novel approved combination regimens (i.e., chemotherapy and immunotherapy) followed by cystectomy. Although NAT improves overall survival, individual patient responses are heterogeneous (meaning not all patients experience the same benefit), and patients often experience morbidity.
In this study, the investigators will use the commercially available GSC- Decipher Bladder to analyze tumor tissue and determine the genomic subtype (luminal or basal).
Additionally, circulating tumor cell DNA (ctDNA) will be assessed at several time points in patients receiving NAT followed by RC, compared with those receiving upfront cystectomy.
- Conditions
- Bladder Cancer
- Being tested
- Neoadjuvant Therapy, Upfront radical cystectomy
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients will undergo standard of care neoadjuvant therapy followed by radical cystectomy
Upfront radical cystectomyProcedure or surgery
Patients will undergo upfront radical cystectomy without neoadjuvant therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Upfront radical cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
: 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.
Measured: 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
Change From Baseline in Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) Bladder Cancer Subscale (BlCS) Score
Measured: Baseline and 1, 3, and 6 months after radical cystectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start10 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saum Ghodoussipour, Rutgers, The State University of New Jersey
- Investigators
- Saum Ghodoussipour, MD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762586
- Sponsor's protocol ID
- 082505
- Status last verified
- Aug 2026
- First submitted
- 1 May 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Luminal Bladder Cancer Effective Response to Neoadjuvant Chemotherapy (LUMBER-NAC)
- ClinicalTrials.gov ID
- NCT07762586
- Acronym / sponsor ID
- 082505
- Conditions
- Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 10 Jul 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The goal of this study is to assess the feasibility and oncologic safety of upfront radical cystectomy in luminal MIBC, using pathological upstaging (pT3-4 or pN+) and efficacy as the primary safety endpoints.
For patients with muscle-invasive bladder cancer (MIBC), the standard treatment remains sequential neoadjuvant therapy (NAT), which may include either cisplatin-based chemotherapy or novel approved combination regimens (i.e., chemotherapy and immunotherapy) followed by cystectomy. Although NAT improves overall survival, individual patient responses are heterogeneous (meaning not all patients experience the same benefit), and patients often experience morbidity.
In this study, the investigators will use the commercially available GSC- Decipher Bladder to analyze tumor tissue and determine the genomic subtype (luminal or basal).
Additionally, circulating tumor cell DNA (ctDNA) will be assessed at several time points in patients receiving NAT followed by RC, compared with those receiving upfront cystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Systemic Therapy Followed by Radical Cystectomy | Active comparator | Drug: Neoadjuvant Therapy, Procedure: Upfront radical cystectomyParticipants 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. |
| Upfront Radical Cystectomy | Experimental | Procedure: Upfront radical cystectomyParticipants proceed directly to radical cystectomy with urinary diversion without receiving initial neoadjuvant systemic therapy. Intervention: Radical Cystectomy With Urinary Diversion |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- ▪ Inclusion Criteria
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neoadjuvant TherapyPatients will undergo standard of care neoadjuvant therapy followed by radical cystectomy | Drug | Neoadjuvant Systemic Therapy Followed by Radical Cystectomy |
| Upfront radical cystectomyPatients will undergo upfront radical cystectomy without neoadjuvant therapy | Procedure or surgery | Neoadjuvant Systemic Therapy Followed by Radical Cystectomy, Upfront Radical Cystectomy |
Primary outcome
: Pathological upstaging rate at radical cystectomy (pT3-pT4 or pN+)
Time frame: At the time of radical cystectomy
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.
1 secondary outcome
Change From Baseline in Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) Bladder Cancer Subscale (BlCS) Score
Time frame: Baseline and 1, 3, and 6 months after radical cystectomy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Saum Ghodoussipour, MD principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant Therapy and Upfront radical cystectomy in people with Bladder Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saum Ghodoussipour, MD (732-235-2465, sg1621@cinj.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
: Pathological upstaging rate at radical cystectomy (pT3-pT4 or pN+) (time frame: At the time of radical cystectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.