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Pembrolizumab in Muscle-invasive Bladder Cancer
NCT05406713 · View on ClinicalTrials.gov ↗
Study Summary
Subjects with cT2-T3N0M0 urothelial cancer of the bladder will be enrolled. After completing two cycles of pembrolizumab, subjects will undergo a restaging MRI of the abdomen and pelvis with a standard acquisition protocol (as outlined in the protocol) as well as CT chest. A CT of the abdomen and pelvis may be performed if there are contraindications to MRI. Patients will also undergo a restaging cystoscopy and biopsies/TURBT as outlined in the protocol. Patients achieving a clinical complete response to treatment (defined in the protocol) will proceed with "maintenance" single agent pembrolizumab followed by surveillance. All other patients will proceed with standard of care local therapy as per their treating physicians followed by "adjuvant" pembrolizumab.
Conditions Studied
Interventions
- DRUG Pembrolizumab
Study Locations (4)
California
- City of Hope — Duarte
Indiana
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis
New Mexico
- University of New Mexico Comprehensive Cancer Center — Albuquerque
New York
- Icahn School of Medicine at Mount Sinai — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2022-07-13 |
| Est. Completion | 2028-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05406713
The ClinicalTrials.gov registry entry for NCT05406713 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Matthew Galsky, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Urothelial Carcinoma appearing as the primary indexed condition, and to 1 intervention — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05406713 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, Indiana, New Mexico. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05406713 about?
NCT05406713 is a clinical study titled "Pembrolizumab in Muscle-invasive Bladder Cancer". Subjects with cT2-T3N0M0 urothelial cancer of the bladder will be enrolled. After completing two cycles of pembrolizumab, subjects will undergo a restaging MRI of the abdomen and pelvis with a standard acquisition protocol (as outlined in the protocol) as well as CT chest. A CT of the abdomen and pe...
What is the current status of trial NCT05406713?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2022-07-13. Estimated completion is 2028-01.
What conditions does trial NCT05406713 study?
This clinical trial studies the following conditions: Urothelial Carcinoma, Muscle Invasive Bladder Carcinoma, Localized Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05406713?
The interventions under investigation include: Pembrolizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05406713?
This trial is sponsored by Matthew Galsky, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05406713 being conducted?
This trial has 4 study locations across California, Indiana, New Mexico, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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