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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01928394
Recruitment Status : Active, not recruiting
First Posted : August 23, 2013
Results First Posted : March 24, 2020
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Solid Tumors Biological: Nivolumab Biological: Ipilimumab Drug: Cobimetinib Phase 1 Phase 2

Detailed Description:

All tumor types are now closed for enrollment:

Triple Negative Breast Cancer

Gastric Cancer

Pancreatic Cancer

Small Cell Lung Cancer

Bladder Cancer

Ovarian Cancer

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab in Subjects With Advanced or Metastatic Solid Tumors
Actual Study Start Date : October 7, 2013
Actual Primary Completion Date : February 5, 2019
Estimated Study Completion Date : October 24, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm N - Nivolumab
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Biological: Nivolumab
Other Names:
  • BMS-936558
  • MDX-1106

Experimental: Arm N-I, Level 1: Nivolumab+Ipilimumab
Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 1 mg/kg solution every 3 weeks for 4 doses followed by Nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Biological: Nivolumab
Other Names:
  • BMS-936558
  • MDX-1106

Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016
  • MDX-010

Experimental: Arm N-I, Level 2: Nivolumab+Ipilimumab
Nivolumab 1 mg/kg solution intravenously plus Ipilimumab 3 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Biological: Nivolumab
Other Names:
  • BMS-936558
  • MDX-1106

Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016
  • MDX-010

Experimental: Arm N-I, Level 2b: Nivolumab+Ipilimumab
Nivolumab 3 mg/kg solution intravenously plus Ipilimumab 1 mg/kg every 3 weeks for 4 doses followed by nivolumab 3 mg/kg every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Biological: Nivolumab
Other Names:
  • BMS-936558
  • MDX-1106

Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016
  • MDX-010

Experimental: Arm N-I, Level 2c: Nivolumab+Ipilimumab
Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Biological: Nivolumab
Other Names:
  • BMS-936558
  • MDX-1106

Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016
  • MDX-010

Experimental: Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib
Nivolumab 3 mg/kg solution intravenously every 3 weeks combined with ipilimumab 1 mg/kg every 6 weeks and cobimetinib 60mg once daily 21days on/7 days off until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Biological: Nivolumab
Other Names:
  • BMS-936558
  • MDX-1106

Biological: Ipilimumab
Other Names:
  • Yervoy
  • BMS-734016
  • MDX-010

Drug: Cobimetinib
Other Name: Cotellic




Primary Outcome Measures :
  1. Objective Response Rate ( ORR ) [ Time Frame: 60 months ]
    The number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Inclusion Criteria:

  • Subjects with histologically or cytologically 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928394


Locations
Hide Hide 38 study locations
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United States, Alabama
Northwest Alabama Cancer Center, Pc
Muscle Shoals, Alabama, United States, 35661
United States, Colorado
University Of Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
United States, Florida
University Of Florida
Gainesville, Florida, United States, 32610
H. Lee Moffitt Cancer Center & Research Inst, Inc
Tampa, Florida, United States, 33612
United States, Georgia
Winship Cancer Institute.
Atlanta, Georgia, United States, 30322
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana Farber/Partners Cancercare, Inc.
Boston, Massachusetts, United States, 02215
Dana-Farber/ Partners Cancer Care, Inc.
Boston, Massachusetts, United States, 02215
United States, Nebraska
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Memorial Sloan Kettering Nassau
New York, New York, United States, 10065
United States, North Carolina
Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Duke Cancer Institute
Durham, North Carolina, United States, 27710
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Tennessee
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
Vanderbilt-Ingram Cancer Ctr
Nashville, Tennessee, United States, 37232
United States, Texas
The University Of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Denmark
Local Institution
Copenhagen, Denmark, 2100
Finland
Local Institution
Helsinki, Finland, 00029
Local Institution
Tampere, Finland, 33521
Germany
Local Institution
Bonn, Germany, 53105
Local Institution
Frankfurt, Germany, 60488
Local Institution
Heidelberg, Germany, 69120
Local Institution
Kassel, Germany, 34125
Italy
Azienda Ospedaliera S.Orsola-Malpighi
Bologna, Italy, 40138
Local Institution
Milano, Italy, 20133
Local Institution
Napoli, Italy, 80131
Istituto Oncologico Veneto IOV
Padova, Italy, 35128
Spain
Local Institution
Barcelona, Spain, 08036
Local Institution
Madrid, Spain, 28040
Local Institution
Madrid, Spain, 28041
Local Institution
Madrid, Spain, 28050
United Kingdom
Local Institution
London, Greater London, United Kingdom, SW3 6JJ
Local Institution
Glasgow, Lanarkshire, United Kingdom, G12 0YN
Local Institution
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] October 3, 2019
Statistical Analysis Plan  [PDF] November 12, 2017

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01928394    
Other Study ID Numbers: CA209-032
2013-002844-10 ( EudraCT Number )
First Posted: August 23, 2013    Key Record Dates
Results First Posted: March 24, 2020
Last Update Posted: August 11, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents