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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Melanoma

Treatments: Drug: Dacarbazine; Drug: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02545075

CA184-248

Details and patient eligibility

About

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.

Enrollment: 182 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:

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

Ipilimumab

Experimental group

Description:

Intravenously (IV) 3 mg/kg every 3 weeks (at week 1,4,7,10) and thereafter (q3w/4 doses) at the time of progression

Treatment:

Drug: Ipilimumab

Dacarbazine

Experimental group

Description:

IV solution 250 mg/m2 (Day 1-5, every 3weeks/at week 1, 4, 7, 10,13,16,19,22)

Treatment:

Drug: Dacarbazine