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for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:



To assess the safety and tolerability and preliminary anti-tumor activity of lirilumab (BMS-986015) given in combination with nivolumab (BMS-936558) and to identify dose limiting toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination. In addition, to assess the combinations of lirilumab and nivolumab or lirilumab and nivolumab plus ipilimumab (BMS-734016) in subjects with advanced (metastatic and/or unresectable) refractory solid tumors.

Official Title

A Phase 1/2 Study of the Combination of Lirilumab (Anti-KIR) Plus Nivolumab (Anti-PD-1) or Lirilumab Plus Nivolumab and Ipilimumab in Advanced Refractory Solid Tumors


CANCER,NOS Neoplasms Nivolumab Antibodies, Monoclonal Immunoglobulins


For people ages 18 years and up

For more information regarding BMS clinical trial participation, please visit

Inclusion Criteria:

  • During dose escalation, subjects with advanced solid tumors (except for primary CNS metastases) that have progressed following at least one standard regimen
  • During cohort expansion, subjects with various solid tumors that have received at least one and no more than 5 prior treatment regimens
  • Subjects must have measurable disease
  • Subject must consent to provide previously collected tumor tissue
  • Women and men ≥18 years of age with performance status of 0 or 1
  • At least 4 weeks since any previous treatment for cancer

Exclusion Criteria:

  • Active or chronic autoimmune diseases
  • Uncontrolled or significant cardiovascular disease
  • Chronic hepatitis (except for subjects with hepatocellular carcinoma)
  • Active infection
  • Active Central nervous system (CNS) metastases
  • Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome((HIV/AIDS)
  • Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except for subjects with hepatocellular carcinoma)

Other protocol defined inclusion/exclusion criteria could apply


  • Ucsf
    San Francisco, California, 94115, United States
  • University Of California San Diego Moores Cancer Center
    La Jolla, California, 92093-0987, United States
  • Local Institution
    Salt Lake City, Utah, 84106, United States
  • Providence Portland Med Ctr
    Portland, Oregon, 97213, United States
  • University Of Washington
    Seattle, Washington, 98195, United States
  • Texas Oncology-Central Austin Cancer Center
    Austin, Texas, 78731, United States
  • University Of Texas Medical Branch Of Galveston
    Galveston, Texas, 77555, United States
  • West Cancer Center
    Germantown, Tennessee, 38138, United States
  • University Of Chicago Medical Center
    Chicago, Illinois, 60637, United States
  • Sacred Heart Medical Oncology Group
    Pensacola, Florida, 32504, United States
  • The Ohio State University Wexner Medical Center
    Columbus, Ohio, 43210, United States
  • Lewis Hall Singletary Oncology Center
    Thomasville, Georgia, 31792, United States
  • UPMC Eye and Ear Institute
    Pittsburgh, Pennsylvania, 15213, United States
  • Juravinski Cancer Center
    Hamilton, Ontario, L8V 5C2, Canada
  • Princess Margaret Cancer Centre
    Toronto, Ontario, M5G 2M9, Canada
  • Florida Cancer Affiliates - Ocala
    Ocala, Florida, 34471, United States
  • Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
    Lutherville, Maryland, 21093, United States
  • Thomas Jefferson University Hospital
    Philadelphia, Pennsylvania, 19107, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York, 10065, United States
  • Beth Israel Deaconess Med Ctr
    Boston, Massachusetts, 02215, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts, 02215, United States
  • Massachusetts General Hospital
    Boston, Massachusetts, 02215, United States
  • Local Institution
    Essen, 45147, Germany
  • Local Institution
    Heidelberg, 69120, Germany
  • Local Institution
    Bordeaux, 33075, France
  • Local Institution
    Lyon Cedex 08, 69373, France
  • Local Institution
    Nice Cedex 2, 06189, France
  • Local Institution
    Paris, 75005, France
  • Local Institution
    Villejuif Cedex, 94805, France
  • Local Institution
    Barcelona, 08035, Spain
  • Local Institution
    Madrid, 28034, Spain
  • Local Institution
    Madrid, 28050, Spain
  • Kantonsspital Graubuenden
    Chur, 7000, Switzerland
  • Centre Hospitalier Universitaire Vaudois
    Lausanne, 1011, Switzerland
  • Local Institution
    Milano, MI, 20133, Italy
  • Local Institution
    Siena, 53100, Italy
  • Local Institution
    Singapore, 119082, Singapore
  • Local Institution
    Singapore, 169610, Singapore


in progress, not accepting new patients
Start Date
Completion Date
Bristol-Myers Squibb
BMS Clinical Trial Information
FDA Safety Alerts and Recalls
Investigator Inquiry Form
BMS clinical trial educational resource
Phase 1/2
Study Type
Last Updated
February 28, 2018