Nivolumab (BMS-936558; MDX-1106) in Combination With Sunitinib, Pazopanib, or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma (RCC) (CheckMate 016)



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/2/2017
Start Date:January 2012
End Date:June 2018

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A Phase 1 Study of Nivolumab (BMS-936558) Plus Sunitinib, Pazopanib or Ipilimumab in Subjects With Metastatic Renal Cell Carcinoma

The purpose is to determine the safety, effectiveness and best dose to use when giving
Nivolumab in combination with Sunitinib, Pazopanib, or Ipilimumab for the treatment of
metastatic renal cell carcinoma.


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

Inclusion Criteria:

- Subjects with histological confirmation of RCC

- Advanced or metastatic disease

- Measurable disease as defined by RECIST 1.1 criteria

- Karnofsky Performance Status (KPS) ≥80%

- Available tumor tissue (archival or recent acquisition)

- Subjects enrolled in the I-1, I-3 expansion arms and IN-3 addition arms must not have
received any prior systemic therapy for RCC with the following exceptions:

1. One prior adjuvant or neoadjuvant therapy for localized or locally advanced RCC
is allowed provided recurrence occurred ≥ 6 months after the last dose of the
adjuvant or neoadjuvant therapy

2. Only prior cytokine based treatment for metastatic RCC [eg, interferon-alpha
(IFN-alpha) or interleukin 2 (IL-2)] as prior therapy is allowed

Exclusion Criteria:

- Active central nervous system (CNS) metastases

- Active or history of autoimmune disease

- Ongoing symptomatic cardiac dysrhythmias or uncontrolled atrial fibrillation

- History of cerebrovascular accident including transient ischemic attack within the
past 12 months

- History of pulmonary embolism or deep vein thrombosis (DVT) within the past 6 months

- Chronic systemic steroids (>10 mg/day Prednisone equivalents) or any other
immunosuppressive agents

- White blood cell (WBC) <2,000/mm3

- Neutrophiles <1,500/mm3

- Platelets <100,000/mm3

- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >3x upper limit of
normal (ULN)

- Total Bilirubin >1.5x ULN (except subjects with Gilbert syndrome, total bilirubin
<3.0 mg/dL)

- Cardiac ejection fraction
- Serum creatinine >1.5x ULN or creatinine clearance <40 mL/min (Cockroft-Gault
formula)

Exclusion Criteria for Arm S and Arm P only:

- For dose escalation cohorts - subjects who received prior Sunitinib or Pazopanib and
required permanent discontinuation due to toxicity or required dose reduction or
delay during the first 12 weeks of therapy due to toxicity, or received both prior
Sunitinib and Pazopanib

- Poorly controlled hypertension

- Active bleeding or bleeding susceptibility
We found this trial at
11
sites
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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Baltimore, Maryland 21231
410-955-6190
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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Baltimore, MD
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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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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Calgary, Alberta
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Calgary,
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Charlotte, North Carolina 28211
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Charlotte, NC
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Duarte, California 91010
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Duarte, CA
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Nashville, TN
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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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Philadelphia, Pennsylvania 19111
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Philadelphia, PA
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