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 |
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.
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
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
450 Brookline Avenue
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Phone: 617-632-5115
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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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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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2220 Pierce Ave
Nashville, Tennessee 37232
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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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
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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20 Duke Clinic Cir
Durham, North Carolina 27710
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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1515 Holcombe Blvd
Houston, Texas 77030
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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Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
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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Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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1275 York Ave
New York, New York 10021
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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