A Phase 3 interventional study of Stent placement and Alvimopan in Bladder Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Recruiting at 7 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 3, Interventional, and Treatment
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Among 47 studies in Urinary Bladder Neoplasms by Memorial Sloan Kettering Cancer Center — 4 open to participants now, 13 under way, 1 of them phase 3. Urinary Bladder Neoplasms · Memorial Sloan Kettering Cancer Center.
Among the 47 studies in Urinary Bladder Neoplasms by Memorial Sloan Kettering Cancer Center, this one is the 3rd largest by planned enrollment of the 38 interventional ones that give a count, is the only one that started in 2024, is one of 4 in phase 3, reaches primary completion later than 11 of the 12 other live ones, and was the 45th registered.
1,800 studies on the registry are indexed under Urinary Bladder Neoplasms; 446 are open to participants now.
Browse Urinary Bladder Neoplasms studies →4 of the 47 studies in Urinary Bladder Neoplasms by Memorial Sloan Kettering Cancer Center are open now, in 1 country. Recruiting first, the newest first:
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 18+
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 18+
Memorial Sloan Kettering Cancer Center · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 336 Urinary Bladder Neoplasms studies recruiting now, 256 (76%) set no upper age limit and 22 (7%) stop at 75 or younger; 22 take children under 18; 21 take healthy volunteers.
This study: 21 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
47 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 24 · Phase 3 4
First in 1995; this study’s year is marked. 1 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 530 is above the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.
Median enrollment 43 across the 38 interventional studies, 116 across the 7 observational. Of the 33 that completed or were terminated, 15 (45%) have results posted.
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Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 326 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.
11 of the studies in Urinary Bladder Neoplasms by Memorial Sloan Kettering Cancer Center that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02989584Memorial Sloan Kettering Cancer CenterA Phase II Study of Atezolizumab in Combination With Cisplatin + Gemcitabine Before Surgery to Remove the Bladder Cancer | 2026-12 |
| NCT03520491Memorial Sloan Kettering Cancer CenterA Study to Test the Safety of Immunotherapy With Nivolumab Alone or With Ipilimumab Before Surgery for Bladder Cancer Patients Who Are Not Suitable for Chemotherapy | 2027-01 |
| NCT02400944Memorial Sloan Kettering Cancer CenterDeterminants of Bladder Cancer Recurrence Study (The DETER Study) | 2027-03 |
| NCT00579514Memorial Sloan Kettering Cancer CenterGermline Alterations of Tumor Susceptibility Genes in New York Cancer Patients | 2027-03 |
| NCT03504163Memorial Sloan Kettering Cancer CenterPembrolizumab (MK-3475) and Bacillus Calmette-Guérin (BCG) as First-Line Treatment for High-Risk T1 Non-Muscle-Invasive Bladder Cancer (NMIBC) and High-Grade Non-Muscle-Invasive Upper Tract Urothelial Carcinoma (NMI-UTUC)] | 2027-04 |
Add all 11 to your calendar (.ics) → With an account.
Among the 47 studies in Urinary Bladder Neoplasms by Memorial Sloan Kettering Cancer Center, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to look at two standard surgical techniques used during a radical cystectomy and see whether they influence outcomes such as length of stay in the hospital and infections after surgery. This trial will evaluate whether the following surgical methods influence outcomes:
A ureteral stent is a thin tube that is placed in the ureter to drain urine from the kidney. Ureteral stents are often used to promote urine drainage after radical cystectomy, but may come at risk of urinary tract infection.
Alvimopan is a standard drug used to promote return of bowel function following surgery. Doctors do not know whether alvimopan is beneficial in current clinical practice.
The surgeon will decide whether participants will receive a stent and/or alvimopan, but if they are unsure what the best approach is, a surgical technique has been assigned by chance to them.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Stent vs. no stent
Exclusion Criteria:
Stent vs. no stent
Alvimopan vs. no alvimopan
For patients treated by a surgeon randomized to use ureteral stents, the operating surgeon may choose to use a single or double J ureteral stent (6- to 8.5-fr in size) or an alternative ureteral stent of the surgeon's choice to be placed across the ureteroenteric anastomosis intraoperatively. Because there is no standard ureteral stent size or type, the surgeon will select a stent type and size according to their experience and will document the stent size and type used. This is already routinely recorded as part of the standard of care at MSK.
Procedure: Stent placement
For patients randomized to receive alvimopan, the patient will receive alvimopan as a fixed 12-mg dose, with the first dose administered 0.5 to 5 h before the start of surgery; administration will be continued with twice daily oral doses postoperatively until hospital discharge or a maximum of 7 days (15 in-hospital doses), as indicated on the medication's FDA label. This is the current standard of care for most cases at MSK.
Drug: Alvimopan
Surgeon may choose to use a single or double J ureteral stent (6- to 8.5-fr in size) or an alternative ureteral stent of the surgeon's choice.
Patient will receive alvimopan as a fixed 12-mg dose, with the first dose administered 0.5 to 5 h before the start of surgery; administration will be continued with twice daily oral doses postoperatively until hospital discharge or a maximum of 7 days (15 in-hospital doses).
Length of hospital stay (Alvimopan)
it will define success for the intervention as a length of stay \<6 days (6 days is the current median length of stay).
Time frame: greater than 6 days
Symptomatic urinary tract infections (Stents)
defined as the presence of signs or symptoms indicative of infection (fever, flank or abdominal pain, leukocytosis, radiographic imaging consistent with pyelonephritis) and a positive urine culture (\>100,000 CFU pathogenic bacteria on an appropriately collected urine specimen).
Time frame: within 30 days of surgery
Plan to share: Yes — Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Started Nov 2024 (actual). Primary completion is estimated for Nov 2028, 48 months after the start.
Of 73 phase 3 interventional studies under Urinary Bladder Neoplasms, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 40 and three quarters within 87. This study's planned 48 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Alvimopan
Memorial Sloan Kettering Cancer Center →