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

January 8, 2024 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1163

Phase

  • Phase 2
  • Phase 1

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0038
  • Denmark
      • Copenhagen, Denmark, 2100
        • Local Institution - 0039
  • Finland
      • Tampere, Finland, 33521
        • Local Institution - 0036
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00290
        • Local Institution - 0014
  • Germany
      • Bonn, Germany, 53105
        • Local Institution
      • Frankfurt, Germany, 60488
        • Local Institution - 0026
      • Heidelberg, Germany, 69120
        • Local Institution - 0016
      • Kassel, Germany, 34125
        • Local Institution
  • Italy
      • Bologna, Italy, 40138
        • Local Institution - 0024
      • Milano, Italy, 20133
        • Local Institution - 0019
      • Napoli, Italy, 80131
        • Local Institution - 0020
      • Padova, Italy, 35128
        • Local Institution - 0032
  • Spain
      • Barcelona, Spain, 08036
        • Local Institution - 0037
      • Madrid, Spain, 28040
        • Local Institution
      • Madrid, Spain, 28050
        • Local Institution - 0010
      • Madrid, Spain, 28041
        • Local Institution - 0017
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, SW3 6JJ
        • Local Institution
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G12 0YN
        • Local Institution - 0012
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Local Institution
  • United States
    • Alabama
      • Muscle Shoals, Alabama, United States, 35661
        • Local Institution - 0047
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Local Institution - 0015
    • Florida
      • Gainesville, Florida, United States, 32610
        • Local Institution - 0046
      • Tampa, Florida, United States, 33612
        • Local Institution - 0021
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Local Institution - 0001
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Local Institution - 0004
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber/Partners Cancercare, Inc.
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0005
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Local Institution - 0049
    • New York
      • Mineola, New York, United States, 11501
        • Local Institution - 0045
      • New York, New York, United States, 10065
        • Local Institution - 0006
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Local Institution - 0003
      • Durham, North Carolina, United States, 27710
        • Local Institution - 0008
    • Oregon
      • Portland, Oregon, United States, 97239
        • Local Institution - 0007
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Local Institution - 0011
      • Nashville, Tennessee, United States, 37232
        • Local Institution - 0002
    • Texas
      • Houston, Texas, United States, 77030
        • Local Institution - 0009
    • Washington
      • Seattle, Washington, United States, 98104
        • Local Institution - 0042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • BMS-734016
  • MDX-010
  • Yervoy
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:
  • BMS-734016
  • MDX-010
  • Yervoy
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:
  • BMS-734016
  • MDX-010
  • Yervoy
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:
  • BMS-734016
  • MDX-010
  • Yervoy
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:
  • BMS-734016
  • MDX-010
  • Yervoy
Drug: Cobimetinib
Other Names:
  • Cotellic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2013

Primary Completion (Actual)

February 5, 2019

Study Completion (Estimated)

May 30, 2024

Study Registration Dates

First Submitted

August 21, 2013

First Submitted That Met QC Criteria

August 21, 2013

First Posted (Estimated)

August 23, 2013

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-032
  • 2013-002844-10 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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