Phase 2 Study of Ipilimumab in Japanese Advanced Melanoma Patients

Sponsor
Bristol-Myers Squibb
Study ID
NCT01990859
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Dec 31, 2013
Status verified
Feb 2016
Primary completion
May 31, 2014
Completion
Feb 28, 2015

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Ipilimumab
    Ipilimumab Intravenous Injection 3 mg/kg for every 3 weeks upto 4 doses

Primary Outcome Measure

Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation of Study Drug, Related AEs, Immune-related AEs (IrAEs) at Primary Endpoint - All Treated Participants [ Time Frame: Day 1 to 90 Days after the last dose, up to May 2014 ]

Related Studies