Clinical Trials Detalhe
A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172)
General Information
Gender
ALL
Age
N/A
Phase
PHASE2
Study Type
INTERVENTIONAL
Location
Local Institution (Lisbon, Portugal)
Local Institution (Porto, Portugal)
Clinicaltrial.gov
https://classic.clinicaltrials.gov/ct2/show/NCT02156804Summary
The purpose of this study is to determine the rate and frequency of high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select adverse events in subjects with histologically confirmed stage III (unresectable) or stage IV melanoma and progression post prior treatment containing an anti-Cytotoxic T Lymphocyte Antigen (CTLA-4) monoclonal antibody, treated with Nivolumab (BMS-936558) at a dose of 3 mg/kg every two weeks.
Conditions
Melanoma
Eligibility
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Subjects with histologically confirmed malignant melanoma * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): * PS 0 to 1 * PS 2 * Previously treated unresectable stage III or stage IV melanoma as per the American Joint Committee on Cancer 2010 Guidelines regardless of BRAF mutation status * Subjects must have experienced evaluable Response Evaluation Criteria In Solid Tumors (RECIST 1.1)-defined disease progression * Prior treatment with chemotherapy, interferon (adjuvant setting), Interleukin (IL-2), BRAF/MEK inhibitors for subjects with known BRAF mutations, Mitogen-activated or extracellular signal- regulated protein kinase (MEK) inhibitors for Neuroblastoma Ras Viral (v-ras) oncogene homolog (NRAS) mutations, and cKIT inhibitor subjects with known cKIT mutations are allowed * Patients with CNS metastases are eligible: * if CNS metastases are treated, patients are asymptomatic or neurologically returned to baseline * if they have previously untreated CNS metastases and are asymptomatic * if they have leptomeningeal metastases, are treated and asymptomatic or neurologically returned to baseline with life expectancy \> 3 months * Patients with a known history of Grades 3-4 immune-related adverse reactions during/after anti-CTLA-4 therapy if all toxicities have resolved at least to Grade 1 Exclusion Criteria: * Subjects with untreated, active Central Nervous System (CNS) metastases are excluded