A Phase 1 Study of Nivolumab (BMS-936558) in Subjects With Advanced or Recurrent Malignancies



Status:Active, not recruiting
Conditions:Lung Cancer, Prostate Cancer, Skin Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/4/2018
Start Date:January 22, 2009
End Date:May 14, 2019

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A Phase 1, Open-Label, Multicenter, Multidose, Dose Escalation Study of BMS-936558 (Nivolumab) in Subjects With Selected 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.


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
We found this trial at
13
sites
Scottsdale, Arizona 85258
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
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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9801 W. Kincey Ave
Huntersville, North Carolina 28078
704-947-6599
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Huntersville, NC
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Nashville, TN
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Tampa, FL
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Ann Arbor, Michigan 48109
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Ann Arbor, MI
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
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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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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Cincinnati, OH
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3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Nashville, TN
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New Haven, CT
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1275 York Ave
New York, New York 10021
(212) 639-2000
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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