A Study of an Anti-KIR Antibody Lirilumab in Combination With an Anti-PD1 Antibody Nivolumab and Nivolumab Plus an Anti-CTLA-4 Ipilimumab Antibody in Patients With Advanced Solid Tumors

Completed · Phase 1/Phase 2

Conditions studied: CANCER,NOS

In brief

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.

Key facts

Study ID

NCT01714739

Run by

Bristol-Myers Squibb

People needed

337

Starts

2012-10-07

Expected to finish

2019-12-13

Last updated by the study team

2023-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ucsf — San Francisco, California, United States
• Florida Cancer Affiliates - Ocala — Ocala, Florida, United States
• University Of Chicago Medical Center — Chicago, Illinois, United States
• Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins — Lutherville, Maryland, United States
• Beth Israel Deaconess Med Ctr — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Providence Portland Med Ctr — Portland, Oregon, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• UPMC Eye and Ear Institute — Pittsburgh, Pennsylvania, United States
• West Cancer Center — Germantown, Tennessee, United States
• Texas Oncology-Central Austin Cancer Center — Austin, Texas, United States
• University Of Texas Medical Branch Of Galveston — Galveston, Texas, United States
• University Of Washington — Seattle, Washington, United States
• Juravinski Cancer Center — Hamilton, Ontario, Canada
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• Local Institution — Bordeaux, France
• Local Institution — Lyon, France
• Local Institution — Nice, France
• Local Institution — Paris, France
• Institut Gustave Roussy — Villejuif, France
• IRCCS Istituto Nazionale Tumori Milano — Milan, MI, Italy
• Local Institution — Siena, Italy

Full record on ClinicalTrials.gov

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