Phase 2 Study of Ipilimumab Plus Dacarbazine in Japanese Patients With Previously Untreated Unresectable or Metastatic Melanoma
Phase 2
20 Years
N/A
20 Years
N/A
Open (Enrolling)
Both
Melanoma
Both
Melanoma
Trial Information
Phase 2 Study of Ipilimumab Plus Dacarbazine in Japanese Patients With Previously Untreated Unresectable or Metastatic Melanoma
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
At 1 year after start of study drugs treatment
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
CA184-202
NCT ID:
NCT01681212
Start Date:
October 2012
Completion Date:
March 2017
Related Keywords:
- Melanoma
- Melanoma
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