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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 : January 10, 2024
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1163 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 24, 2013
Actual Primary Completion Date : February 5, 2019
Estimated Study Completion Date : May 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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.


Eligibility Criteria
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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
Contacts and Locations
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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
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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

More Information
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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: January 10, 2024
Last Verified: January 2024

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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
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action