A study to compare BMS-936558 to the physician’s choice of either dacarbazine or carboplatin and paclitaxel in advanced melanoma patients that have progressed following anti-CTLA-4 therapy
- Conditions
- nresectable or metastatic melanomaMedDRA version: 19.0Level: LLTClassification code 10027481Term: Metastatic melanomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-001828-35-NL
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 520
1) men & women = 18 years of age
2) ECOG PS 0-1
3) Histologically confirmed Stage III (unresectable)/Stage IV melanoma
4) Measurable disease by CT/MRI per RECIST 1.1 criteria
5) Objective evidence of disease progression (clinical or radiological) during or after at least 1 (V600 Wildtype) or at least 2 (V600 mutation positive) prior treatment regimens
6) Pre-treatment fresh core, excision or punch biopsy.
7) Archival FFPE tumor material if available.
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 364
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 156
1) Any treatment in a BMS-936558 trial.
2) Subjects with condition requiring systemic treatment with either corticosteroids (> 10mg QD prednisone/equivalent) or other immunosuppressive medications within 14 days of study drug administration.
3) Active, known or suspected autoimmune disease
4) Unknown BRAF status
5) Active brain metastasis or leptomeningeal metastasis.
6) Ocular melanoma
7) Prior therapy with anti-PD-1, anti-PD-L1 or anti-PD-L2.
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