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NCT01524991 · ClinicalTrials.gov registry record · Phase 2
First-Line Gemcitabine, Cisplatin + Ipilimumab for Metastatic Urothelial Carcinoma
A Phase 2 study of Urothelial Carcinoma, sponsored by Hoosier Cancer Research Network.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 8
- Study locations
NCT01524991: Completed Phase 2 study of Urothelial Carcinoma, sponsored by Hoosier Cancer Research Network.
NCT01524991 is a Phase 2 study of Urothelial Carcinoma that has completed, run by Hoosier Cancer Research Network. The registered enrollment target is 36 participants, below the 239-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (85% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01524991, a Phase 2 study of Urothelial Carcinoma, has completed, sponsored by Hoosier Cancer Research Network.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 8
- Study locations
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.
Primary Outcome
To determine the median overall survival of patients with advanced/metastatic urothelial cancer treated with gemcitabine, cisplatin, plus ipilimumab, calculated from the date of registration until the date of final analysis, projected to be 48 months from the start of the study.
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 |
What the finished NCT01524991 record still lists
NCT01524991 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 239-participant average among 85 other Urothelial Carcinoma trials with a reported enrollment target (85% lower).
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.
NCT01524991 lists 8 locations in 6 states (Indiana, California, Nebraska).
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.
What interventions are being tested in trial NCT01524991?
The interventions under investigation include: Cisplatin (DRUG), Ipilimumab (DRUG), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT01524991?
This trial is sponsored by Hoosier Cancer Research Network, which has 26 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Urothelial Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01524991's enrollment target sits among peer trials
36 60th of 85 higher than 26 of 85 other Urothelial Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urothelial Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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