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



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:2/2/2019
Start Date:October 7, 2012
End Date:October 16, 2019

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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

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.


For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.

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
We found this trial at
17
sites
4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Phone: 503-215-2604
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Portland, OR
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-4292
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Boston, MA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Phone: 617-632-9285
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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Austin, TX
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-582-7545
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Phone: 773-702-1835
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Chicago, IL
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Phone: 614-685-8964
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Columbus, OH
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Galveston, TX
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Germantown, Tennessee 38138
Phone: 901-683-0055
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Germantown, TN
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Hamilton, Ontario
Phone: 9053879495
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Hamilton,
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Lutherville, MD
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-888-3359
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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433 Southwest 10th Street
Ocala, Florida 34471
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Ocala, FL
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Pittsburgh, Pennsylvania 15213
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1635 Divisadero Street
San Francisco, California 94143
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San Francisco, CA
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