CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 99 enrolled
Drug / intervention
Ipilimumabbiological
Likely dose
Ipilimumab 10 mg/kgfrom 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/NCT00920907
NCT00920907Phase 1Completed
CompareCT.gov

A Randomized, Parallel, Open-Label Study to Compare the Pharmacokinetics of Ipilimumab (BMS-734016) Process C to Process B in Subjects With Advanced Melanoma

Bristol-Myers Squibb·interventional·Posted Jun 15, 2009·Updated Jun 20, 2014

In Brief

A Phase 1 clinical trial evaluating Ipilimumab for Advanced Melanoma. Completed, enrolled 99 participants across 7 sites.

Detailed Summary

The purpose of this clinical research study is to compare pharmacokinetics of ipilimumab manufactured by two different processes

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Melanoma
CountriesUnited States
CollaboratorsMedarex

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 15, 2009
Enrollment StartAug 1, 2009
Primary CompletionApr 1, 2010
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 17.0 years ago

Interventions

Ipilimumabbiological

Solution, Intravenous, 10 mg/kg, Every 3 weeks (up to 4 doses) in induction phase, every 12 weeks in maintenance phase, 48 weeks