Clinical Trial VICCMEL12100
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.
- 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
Participants are being asked to take part in this research study because they have advanced melanoma (a type of skin cancer). The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of an investigational drug called nivolumab. Nivolumab is an antibody (a type of human protein) that is being tested to see if it will allow the body's immune system to work against tumor cells.
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
CriteriaFor additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
• 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
• 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
• Pre-treatment fresh core, excision or punch tumor biopsy
• Archival Formalin-fixed paraffin-embedded (FFPE) tumor material if available
• Any treatment in a BMS-936558 (Nivolumab) 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)