A Study of Nivolumab by Itself or Nivolumab Combined With Ipilimumab in Patients With Advanced or Metastatic Solid Tumors



Status:Active, not recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/21/2018
Start Date:October 7, 2013
End Date:December 22, 2020

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A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab in Subjects With Advanced or Metastatic Solid Tumors

To investigate the safety and efficacy of nivolumab as a single agent or in combination with
ipilimumab in 6 tumor types - triple-negative breast cancer (TNBC), gastric cancer (GC),
pancreatic adenocarcinoma (PC), small cell lung cancer (SCLC), bladder cancer (BC), and
ovarian cancer (OC). A combination of nivolumab with ipilimumab and cobimetinib is also
investigated in PC.

All tumor types are now closed for enrollment:

Triple Negative Breast Cancer

Gastric Cancer

Pancreatic Cancer

Small Cell Lung Cancer

Bladder Cancer

Ovarian Cancer

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

Inclusion Criteria:

- Subjects with histologically confirmed locally advanced or metastatic disease of the
following tumor types:

- Triple Negative Breast Cancer

- Gastric Cancer

- Pancreatic Cancer

- Small Cell Lung Cancer

- Bladder Cancer

- Ovarian Cancer

- Subjects must have measurable disease

- Eastern Cooperative Oncology Group (ECOG) of 0 or 1

- Adequate hematological and organ function as confirmed by laboratory values

Exclusion Criteria:

- Active brain metastases or leptomeningeal metastases

- Subjects with active, known or suspected autoimmune disease

- Subjects with a condition requiring systemic treatment with either corticosteroids
(>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14
days of treatment

- Prior therapy with experimental anti-tumor vaccines; any T cell co-stimulation or
checkpoint pathways, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or
anti-CTLA-4 antibody, including Ipilimumab; or other medicines specifically targeting
T cell is also prohibited
We found this trial at
20
sites
259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Mineola, NY
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Baltimore, Maryland 21231
410-955-6190
Phone: 410-955-4429
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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Gainesville, Florida 32610
(352) 392-3261
Phone: 35226506807657
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Phone: 800-811-8480
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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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-494-1080
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Atlanta, Georgia 30322
Phone: 404-712-7485
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Atlanta, GA
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Aurora, Colorado 80045
Phone: 720-848-0755
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Aurora, CO
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450 Brookline Avenue
Boston, Massachusetts 02215
Phone: 617-632-5115
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Boston, MA
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Boston, Massachusetts 02115
Phone: 617-632-5115
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Boston, MA
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Charlotte, North Carolina 28211
Phone: 980-442-2305
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Charlotte, NC
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20 Duke Clinic Cir
Durham, North Carolina 27710
(888) 275-3853
Phone: 919-684-6342
Duke Cancer Institute Leading-edge cancer care and research have been a hallmark of Duke Medicine...
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Durham, NC
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Phone: 713-563-1602
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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Muscle Shoals, Alabama 35661
Phone: 256-764-4200
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Muscle Shoals, AL
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Phone: 615-329-7450
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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New Haven, Connecticut 6520
(203) 432-4771
Phone: 203-737-1889
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Haven, CT
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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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Omaha, Nebraska 68114
Phone: 402-884-7857
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Omaha, NE
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Seattle, Washington 98104
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Seattle, WA
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Tampa, Florida 33612
Phone: 813-745-3883
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Tampa, FL
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Toronto, Ontario
Phone: 416-946-4501
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Toronto,
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