Clinical Trial VICCMEL12100
Title
A Randomized, Open-Label Phase 3 Trial of BMS-936558 versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy.
Principal Investigator(s)
Details
- Protocol No. VICCMEL12100
- Open Date: 01/18/2013
- Staging: Phase III
- Age Group: Adults
- Scope: International
- Objective: To compare the objective response rate (ORR) and overall survival (OS) of BMS-936558 to investigator's choice in subjects with advanced melanoma.
- Disease Sites: Melanoma
- Therapies: Chemotherapy - cytotoxic; Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Carboplatin; Dacarbazine (DTIC); MDX-1106 (BMS-936558); Paclitaxel
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01721746
- Secondary Protocol No: CA209037
Description
None Provided.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
|---|---|
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
• Men & women ≥ 18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
• Histologically confirmed Stage III (unresectable)/Stage IV melanoma
• Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
• RECIST defined disease progression during or after ≤ 2 prior treatment regimens
• Pre-treatment fresh core or excision tumor biopsy.
• Archival Formalin-fixed paraffin-embedded (FFPE) tumor material if available
Exclusion Criteria:
• Any treatment in a BMS-936558 trial
• Subjects with condition requiring systemic treatment with either corticosteroids (> 10mg daily prednisone/equivalent) or other immunosuppressive medications within 14 days of study drug administration
• Active, known or suspected autoimmune disease
• Unknown BRAF status
• Active brain metastasis or leptomeningeal metastasis
• Ocular melanoma
• Prior therapy with anti programmed death-1 (anti-PD-1), anti programmed death-ligand 1 (anti-PD-L1) or anti-programmed death-ligand 2 (anti-PD-L2)
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