Phase 2 Study of Ipilimumab Plus DTIC in Japanese Advanced Melanoma Patients
Phase 2
- Conditions
- Melanoma
- Registration Number
- JPRN-jRCT2080221931
- Lead Sponsor
- Bristol-Myers K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
Histologic diagnosis of malignant melanoma
-Previously untreated Stage III with N3 (unresectable) or Stage IV melanoma
-Life expectancy of at least 16 weeks in this study
-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
-History of or current active autoimmune disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine survival rate defined as the proportion of subjects who are alive after at least one year of follow up following the first dose of study therapy <br>Survival rate at 1 year will be calculated using the number of patients alive at least one year of follow up following the first dose of study therapy.
- Secondary Outcome Measures
Name Time Method To assess frequency of Grade 3-4 Immune-related Adverse Events (irAEs)<br>irAEs will be measured every 3 weeks in induction phase, every 6 weeks in maintenance to Week 48, and every 12 weeks to Progressive Disease (PD)