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First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma
NCT01524991 · View on ClinicalTrials.gov ↗
Study Summary
Gemcitabine plus cisplatin is standard treatment for advanced urothelial cancer. Ipilimumab has shown intriguing activity as neoadjuvant therapy in patients with clinically localized bladder cancer undergoing radical cystectomy. The combination of gemcitabine, cisplatin, plus ipilimumab may build on the chemosensitivity of urothelial carcinoma to produce more durable responses and improved outcomes.
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Ipilimumab
- DRUG Gemcitabine
Study Locations (8)
Indiana
- IU Health Goshen Hospital — Goshen
- Indiana University Melvin & Bren Simon Cancer Center — Indianapolis
- IU Health Central Indiana Cancer Centers — Indianapolis
California
- City of Hope: Duarte — Duarte
Nebraska
- Nebraska Cancer Specialists — Omaha
New York
- Tisch Cancer Institute at Mount Sinai Medical Center — New York
Texas
- Texas Oncology, PA — Dallas
Virginia
- Virginia Oncology Associates — Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-01 |
| Est. Completion | 2018-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01524991
The ClinicalTrials.gov registry entry for NCT01524991 describes a study currently listed as completed. 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 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoosier Cancer Research Network, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Urothelial Carcinoma appearing as the primary indexed condition, and to 3 interventions — of which Cisplatin 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: NCT01524991 reports 8 study locations spanning 6 distinct geographic areas — top geographies include Indiana, California, Nebraska. 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 NCT01524991 about?
NCT01524991 is a clinical study titled "First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma". Gemcitabine plus cisplatin is standard treatment for advanced urothelial cancer. Ipilimumab has shown intriguing activity as neoadjuvant therapy in patients with clinically localized bladder cancer undergoing radical cystectomy. The combination of gemcitabine, cisplatin, plus ipilimumab may build on...
What is the current status of trial NCT01524991?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2012-01. Estimated completion is 2018-12-31.
What conditions does trial NCT01524991 study?
This clinical trial studies the following conditions: Urothelial Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01524991?
The interventions under investigation include: Cisplatin (DRUG), Ipilimumab (DRUG), Gemcitabine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01524991?
This trial is sponsored by Hoosier Cancer Research Network, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01524991 being conducted?
This trial has 8 study locations across California, Indiana, Nebraska, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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