For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

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  • Inclusion Criteria:


    1. Subjects with histologically or cytologically confirmed locally advanced or metastatic disease of the following tumor types:
    2. Triple Negative Breast Cancer
    3. Gastric Cancer
    4. Pancreatic Cancer
    5. Small Cell Lung Cancer
    6. Bladder Cancer
    7. Ovarian Cancer
    8. Subjects must have measurable disease
    9. Eastern Cooperative Oncology Group (ECOG) of 0 or 1
    10. Adequate hematological and organ function as confirmed by laboratory values

    EXCLUSION CRITERIA

    Exclusion Criteria:


    1. Active brain metastases or leptomeningeal metastases
    2. Subjects with active, known or suspected autoimmune disease
    3. Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment
    4. 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

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    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply


    Contact the study center to learn if this study is a good match for you.

    Study’s details


    Contition

    Advanced or Metastatic Solid Tumors

    Age (in years)

    18+

    Phase

    Phase 1/Phase 2

    Participants needed

    1163

    Est. Completion Date

    Dec 31, 2023

    Treatment type

    Interventional


    Sponsor

    Bristol-Myers Squibb

    ClinicalTrials.gov identifier

    NCT01928394

    Study number

    CA209032

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