A Phase 1 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Recurrent Malignancies
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.
Checked against the public recordLast updated Dec 3, 2021 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Bristol-Myers Squibb
- Interventions being studied
- Biological: BMS-936558 (MDX-1106); Biological: BMS-936558 (MDX-1106); Biological: BMS-936558 (MDX-1106); Biological: BMS-936558 (MDX-1106); Biological: BMS-936558 (MDX-1106)
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Pinnacle Oncology HematologyScottsdale, Arizona
- Yale University School Of MedicineNew Haven, Connecticut
- H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida
- Johns Hopkins UniversityBaltimore, Maryland
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts
- Massachusetts General HospitalBoston, Massachusetts
- University Of Michigan Cancer CenterAnn Arbor, Michigan
- Memorial Sloan Kettering NassauNew York, New York
- Carolina Biooncology InstituteHuntersville, North Carolina
- Christ HospitalCincinnati, Ohio
- Sarah Cannon Research InstituteNashville, Tennessee
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 3, 2021. Always confirm current availability with the study team.