CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 248 enrolled
Drug / intervention
Ipilimumabdrug
Likely dose
Ipilimumab 0.3, 3, or 10 mg/kg intravenously every 3 weeks or every 3 monthsAI-extracted
Key inclusion· 6
  • ✓Diagnosis of advanced melanoma
  • ✓Prior enrollment and treatment in a prespecified ipilimumab parent study
  • ✓Age 18 years or older
  • ✓Reinduction cohort: experienced documented progressive disease after initial clinical benefit without unacceptable toxicity requiring discontinuation
Key exclusion· 2
  • ✕Prior treatment with other CD137 agonists, CTLA-4 inhibitors, or CTLA-4 agonists (excluding ipilimumab)
  • ✕Primary ocular or mucosal melanoma

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

Search/NCT00162123
NCT00162123Phase 2Completed
CompareCT.gov

A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010 Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols.

Bristol-Myers Squibb·interventional·Posted Sep 13, 2005·Updated Jul 27, 2016

In Brief

A Phase 2 clinical trial evaluating Ipilimumab for Melanoma. Completed, enrolled 248 participants across 58 sites in 18 countries.

Detailed Summary

The purpose of this study was to evaluate the continued use of ipilimumab in patients who had reinduction at the time of disease progression or to continue maintenance treatment. In addition, this study will continue to follow patients who have taken ipilimumab, but who are not eligible for maintenance or reinduction therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesArgentina, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Israel, Italy, Norway, Poland, Russia, South Africa, Spain, Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 13, 2005
Enrollment StartMay 1, 2006
Primary CompletionSep 1, 2012
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 20.8 years ago

Interventions

Ipilimumabdrug

Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation