Overview

This trial is active, not recruiting.

Condition high risk stage iii melanoma
Treatments ipilimumab, placebo
Phase phase 3
Target CTLA-4
Sponsor Bristol-Myers Squibb
Start date June 2008
End date July 2013
Trial size 1211 participants
Trial identifier NCT00636168, CA184-029, EORTC 18071

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
ipilimumab BMS-734016
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
(Placebo Comparator)
placebo
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

Primary Outcomes

Measure
Recurrence Free Survival (RFS) Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population
time frame: Date of randomization to first date of recurrence or death or last available disease assessment with RFS data up to 5 years. Median follow-up was 2.7 years.
Number of Patients With Recurrence or Death as Per Independent Review Committee (IRC) in the Intent to Treat (ITT) Population
time frame: Date of randomization to first date of recurrence or death or last available disease assessment with RFS data upto 5 years. Median follow-up was 2.7 years.
Recurrence-Free Survival (RFS) Rates Per IRC at 1 Year, 2 Years, and 3 Years in the ITT Population
time frame: Randomization up to Years 1, 2, and 3

Secondary Outcomes

Measure
Number of Patients With Distant Metastasis-Free Survival (DMFS)
time frame: Date of randomization to date of DMFS, up to 5 years
Number of Participants With Overall Survival (OS)
time frame: date of randomization to date of death or last known alive date with OS data upto 5 years.
Number of Patients With Adverse Events (AEs) Leading to Discontinuation of Treatment, Serious AEs (SAEs), Drug-Related SAEs, Immune-related AEs (irAEs), Immune-mediated Adverse Reactions (imARs), Deaths in Treated Population
time frame: Day 1 up to 70 days after last dose or last known alive date for patients still being dosed; up to 5 years
Exposure Adjusted Incidence Rate of Adverse Events Including Multiple Occurrences of Unique Events
time frame: Day 1 up to 70 days after last dose or last known alive date for participants still being dosed; up to 5 years
Mean Change From Baseline in Global Health Status Scores at Each Assessment Timepoint
time frame: Baseline up to 2 years from randomization

Eligibility Criteria

Male or female participants at least 18 years old.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: - Age ≥ 18 years - Complete and adequate resection of Stage III melanoma with histologically confirmed melanoma metastatic to lymph node - Disease-free - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 - Randomization within 12 weeks of surgery Exclusion Criteria: - Prior therapy for melanoma except surgery - Auto-immune disease

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.