A Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine

• Status: Completed
• Trial end date: 2019-04-19
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether Ipilimumab will extend the life of chinese patients with Chemotherapy Naive Stage IV Melanoma more than Dacarbazine as well as to examine safety in this patient population.

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

Details

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

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Chinese males and females ≥ 18 years of age

• Histologic diagnosis of malignant melanoma

• Chemotherapy naive Stage IV melanoma (AJCC 2010)

• Life expectancy of ≥ 16 weeks

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

• Evidence of brain metastases on brain imaging

• Primary ocular or mucosal melanoma

• Any other malignancy from which the patient has been disease-free for less than 5 years

• BRAF status cannot be determined by Screening test

• Human Immunodeficiency Virus (HIV) positive or hepatitis B surface antigen (HBsAg) positive, or active Hepatitis C infection