CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Gemcitabine +2 moredrug
Likely dose
Gemcitabine 1000 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01524991
NCT01524991Phase 2Completed
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Phase II Trial of Gemcitabine, Cisplatin, Plus Ipilimumab as First-line Treatment for Patients With Metastatic Urothelial Carcinoma: Hoosier Cancer Research Network GU10-148

Hoosier Cancer Research Network·interventional·Posted Feb 2, 2012·Updated Jul 11, 2022

In Brief

A Phase 2 clinical trial evaluating Gemcitabine, Cisplatin, and 1 other intervention for Urothelial Carcinoma. Completed, enrolled 36 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrothelial Carcinoma
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2, 2012
Enrollment StartJan 1, 2012
Primary CompletionJul 15, 2017
Study CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 14.4 years ago

Interventions

Gemcitabinedrug

Gemcitabine 1000 mg/m2 Days 1 \& 8 (all cycles)

Cisplatindrug

Cisplatin 70 mg/m2 Day 1 (all cycles)

Ipilimumabdrug

Ipilimumab 10 mg/kg Day 1 (start cycle 3)