CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,211 enrolled
Drug / intervention
ipilimumab +1 moredrug
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/NCT00636168
NCT00636168Phase 3Completed

Adjuvant Immunotherapy With Anti-CTLA-4 Monoclonal Antibody (Ipilimumab) Versus Placebo After Complete Resection of High Risk Stage III Melanoma: A Randomized, Double-blind Phase 3 Trial of the EORTC Melanoma Group

Bristol-Myers Squibb·interventional·Posted Mar 14, 2008·Updated Dec 17, 2019

In Brief

A Phase 3 clinical trial evaluating ipilimumab and Placebo for High Risk Stage III Melanoma. Completed, enrolled 1,211 participants across 97 sites in 19 countries.

Detailed Summary

The purpose of the study is to determine if ipilimumab is effective in preventing or delaying recurrence and prolongs survival after complete resection of high risk stage III melanoma

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 14, 2008
Enrollment StartJun 30, 2008
Primary CompletionJul 26, 2013
Study CompletionNov 26, 2018
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 18.3 years ago

Interventions

ipilimumabdrug

IV solution, IV, 10 mg/kg, 4x every 21 days, then starting from Week 24 every 12 weeks until Week 156 (3 years), disease recurrence, unacceptable toxicity or patient withdrawal

Placebodrug

IV solution, IV, 10 mg/kg, 4x every 21 days then starting from Week 24 every 12 weeks until Week 156 (3 years), disease recurrence, unacceptable toxicity or patient withdrawal