Overview

This trial is active, not recruiting.

Condition melanoma
Treatment ipilimumab
Phase phase 2
Target CTLA-4
Sponsor Bristol-Myers Squibb
Start date December 2013
End date May 2014
Trial size 18 participants
Trial identifier NCT01990859, CA184-396

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Ipilimumab Intravenous Injection 3 mg/kg for every 3 weeks upto 4 doses
ipilimumab BMS-734016

Primary Outcomes

Measure
Safety of Ipilimumab monotherapy based on serious and non-serious adverse events, laboratory evaluations, dose exposure and modifications
time frame: At 12 weeks after first treatment of last subject

Secondary Outcomes

Measure
Best overall response rate (BORR)
time frame: At Screening (Within 28 days of first dose), weeks 12, 18, and 24 and every 12 weeks thereafter for at least 1 year after last subject's first treatment (Approximately 15 months)

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title Phase 2 Study of Ipilimumab in Japanese Subjects With Unresectable or Metastatic Melanoma
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.