A Phase 1 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Recurrent Malignancies
Condition: Metastatic Castration-resistant Prostrate Cancer; Renal Cell Carcinoma; Metastatic Melanoma; Non-small Cell Lung Cancer
MeSH terms: Carcinoma, Renal Cell
Intervention: BMS-936558 (MDX-1106); BMS-936558 (MDX-1106); BMS-936558 (MDX-1106); BMS-936558 (MDX-1106); BMS-936558 (MDX-1106)
Intervention description: Solution, Intravenous, 0.1 mg/kg - 10 mg/kg, Every 2 weeks, 3 years depending on response; Solution, Intravenous, 1 - 10 mg/kg, Every 2 weeks, 3 years depending on response; Solution, Intravenous, 10 mg/kg, Every 2 weeks, 3 years depending on response; Solution, Intravenous, 1 - 10 mg/kg, Every 2 weeks, 3 years depending on response; Solution, Intravenous, 10 mg/kg, Every 2 weeks, 3 years depending on response
Intervention MeSH terms: Nivolumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 395.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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