None listed
Conditions
Interventions
Nivolumab for injection, 3 mg/kg every 2 weeks for a maximum of 2 years.
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Key inclusion criteria (See Section 3.3.1 for the full list of criteria): a) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 b) Histologically confirmed malignant melanoma, including mucosal melanoma c) Previously treated unresectable stage III or stage IV melanoma, as per American Joint Committee on Cancer staging system regardless of BRAF mutation status d) Progressed on or after treatment with an anti-CTLA-4-containing therapy. Prior treatment with other therapies is permitted (eg, chemotherapy) i) Subjects with BRAF mutation positive advanced melanoma must also have progressed on or after treatment with BRAF inhibitor monotherapy or in combination with a MEK inhibitor
Exclusion criteria
Exclusion criteria: Key exclusion criteria (See Section 3.3.2 for the full list of criteria) a) Active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 2 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. There must also be no requirement for high doses of systemic corticosteroids that could result in immunosuppression (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration. b) Subjects with ocular melanoma c) Life expectancy 10 x ULN (2) T. bilirubin > 5 x ULN vi) Subjects who required infliximab or other immune suppressants including mycophenolic acid for management of drug related toxicities vii) History of Grade ≥3 neurologic toxicity viii) History of Grade ≥3 allergy to study drug components. f) Any treatment in a nivolumab trial
Countries
Argentina, Brazil, Chile, Colombia, Peru, United States
Contacts
Public ContactDANTE MONTAÑO
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed