Phase 2 Study of Ipilimumab in Japanese Advanced Melanoma Patients
Phase 2
- Conditions
- Melanoma
- Registration Number
- JPRN-jRCT2080222335
- Lead Sponsor
- Bristol-Myers K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 18
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety<br>Safety of Ipilimumab monotherapy based on serious and non-serious adverse events, laboratory evaluations, dose exposure and modifications. In addition, abnormal vital signs and physical examination findings are also included
- Secondary Outcome Measures
Name Time Method Best overall response rate (BORR)<br>Best Overall Response Rate, defined as the total number of subjects whose Best Overall Response is Complete Response (CR) or Partial Response (PR) divided by the total number of treated subjects.