Phase 3 Trial in Subjects with Metastatic Melanoma Comparing 3 mg/kg Ipilimumab versus 10 mg/kg Ipilimumab
Phase 1
- Conditions
- MelanomaMedDRA version: 16.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-004029-28-SE
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 800
Inclusion Criteria
• Unresectable Stage III or Stage IV melanoma
• ECOG PS 0 or 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 544
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 256
Exclusion Criteria
• Brain metastases with symptoms or requiring treatment
• History of automimmune disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method