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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: High Risk Stage III Melanoma

Treatments: Drug: Placebo; Drug: ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00636168

EORTC 18071

CA184-029

Details and patient eligibility

About

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

Enrollment: 1,211 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,211 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Treatment:

Drug: ipilimumab

B

Placebo Comparator group

Treatment:

Drug: Placebo