a phase 1 study of nivolumab (bms-936558) in subjects with advanced or recurrent malignancies

Conditions: Metastatic Castration-resistant Prostrate Cancer; Renal Cell Carcinoma; Metastatic Melanoma; Non-small Cell Lung Cancer

Summary: the purpose of this study is to determine the safety and effectiveness of mdx-1106 in patients with certain types of cancer. another purpose is to determine how mdx-1106 is absorbed and distributed within the body, and how it's eventually eliminated.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * subjects must have mcrpc,rcc, mel, non-small-cell lung cancer (nsclc), or colorectal cancer (crc), that is advanced (non-resectable), or recurrent and for which no alternative, curative standard exists * eastern cooperative oncology group (ecog) performance status of 0-2 * must have at least 1 measurable lesion * subjects with mcrpc and with only non-measurable bone lesions must have either progression new lesions or have prostate-specific antigen (psa) progression within the 6-week period before study administration * at least 1 and up to 5 prior systemic therapies for advanced/recurrent disease * prior treated brain or meningeal metastases must be without magnetic resonance imaging (mri) evidence of progression for at least 8 weeks and off immunosuppressive doses of systemic steroids for at least 2 weeks before study drug administration * prior systemic radiation therapy must have been completed at least 4 weeks before study drug administration. prior focal radiotherapy completed at least 2 weeks prior to study drug administration * immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids must be discontinued at least 2 weeks before study drug administration * prior surgery that required general anesthesia must be completed at least 2 weeks before study drug administration. surgery requiring local/epidural anesthesia must be completed at least 72 hours before study drug administration exclusion criteria: * history of severe hypersensitivity reactions to other monoclonal antibody (mab)s * subjects with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy * prior therapy with an anti-programmed death-1 (pd-1), anti-pd-l1, anti-pd-l2, or anti- cytotoxic t-lymphocyte antigen-4 (ctla-4) antibody (or any other antibody targeting t cell co-stimulation pathways) * known history of human immunodeficiency virus * active infection requiring therapy, positive tests for hepatitis b surface antigen or hepatitis c ribonucleic acid (rna) * underlying medical conditions that will make the administration of study drug hazardous * concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids * use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration