Phase 2 Study of Ipilimumab in Japanese Advanced Melanoma Patients

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Melanoma

Treatments: Biological: Ipilimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01990859

CA184-396

Details and patient eligibility

About

The purpose of this study is to assess the safety of Ipilimumab monotherapy in Japanese subjects with advanced melanoma

Enrollment: 20 patients

Sex: All

Ages: 20+ 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:

• Histologically or cytologically confirmed diagnosis of malignant melanoma
• Previously-treated or untreated unresectable Stage III or Stage IV melanoma
• Measurable/evaluable disease per modified World Health Organization (mWHO) criteria, within 28 days of first dose of study drug
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

• Active brain metastases
• Primary ocular or mucosal melanoma
• History of or current active autoimmune disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Arm A: Ipilimumab

Experimental group

Description:

Ipilimumab Intravenous Injection 3 mg/kg for every 3 weeks upto 4 doses

Treatment:

Biological: Ipilimumab