CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 72 enrolled
Drug / intervention
Ipilimumab +3 moredrug
Likely dose
Ipilimumab 10mg/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/NCT00796991
NCT00796991Phase 1Completed
CompareCT.gov

A Randomized, Parallel, 3-arm Study to Characterize the Effect of Ipilimumab + Chemotherapy in Patients With Untreated Advanced Melanoma

Bristol-Myers Squibb·interventional·Posted Nov 24, 2008·Updated Jan 6, 2014

In Brief

A Phase 1 clinical trial evaluating Ipilimumab, Carboplatin, and 2 other interventions for Advanced Melanoma. Completed, enrolled 72 participants across 4 sites.

Detailed Summary

The purpose of this clinical research study is to learn the pharmacokinetics of Ipilimumab when combined with Paclitaxel/Carboplatin or Dacarbazine

Study Details

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

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 24, 2008
Enrollment StartFeb 1, 2009
Primary CompletionNov 1, 2009
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.6 years ago

Interventions

Ipilimumabdrug

Solution, intravenous, 10mg/kg, every 3 weeks in the induction phase, up to 4 doses in the induction phase, 48 weeks

Carboplatindrug

Solution, intravenous, Area Under the Concentration Time Curve=6, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks

Paclitaxeldrug

Solution, intravenous, 175 mg/m2, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks

Dacarbazinedrug

Solution, intravenous, 850 mg/m2, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks