Efficacy Study of Ipilimumab Versus Placebo to Prevent Recurrence After Complete Resection of High Risk Stage III Melanoma

• Status: Completed
• Trial end date: 2018-11-26
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Ipilimumab

Criteria

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