First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors

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About the study

The purpose of this study is to determine whether BMS-986218 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors.
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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

  • For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
  • Inclusion Criteria:


    1. Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable)
    2. Eastern Cooperative Oncology Group Performance Status of 0 or 1
    3. Participants must have received, and then progressed, relapsed, or been intolerant to at least 2 standard treatment regimens with proven survival benefit in the advanced or metastatic setting according to tumor type, if such a therapy exists
    4. Advanced stage cutaneous melanoma who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-programmed cell death 1 (anti-PD-1) or anti-programmed death ligand 1 (anti-PD-L1) (For Part 2A)
    5. Non-small cell lung cancer (NSCLC) (adenocarcinoma or squamous cell carcinoma) who have received standard therapies with proven survival benefit including prior immunotherapy with an anti-PD-1 or anti-PD-L1 (For Parts 2B & 2C)
    6. Microsatellite Stable Colorectal Cancer (MSS CRC) who have received standard therapies with proven survival benefit (Part 2D)

    EXCLUSION CRITERIA

    Exclusion Criteria:


    1. Participants with primary CNS malignancies, or tumors with CNS metastases as the only site of disease, will be excluded
    2. Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
    3. Prior anti-cancer treatments such as chemotherapy, radiotherapy, hormonal, or immunotherapy (including anti-PD-1/PD-L1) are permitted

    Other protocol-defined inclusion/exclusion criteria apply


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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 Details


    Contition
    Advanced Cancer
    Age (in years)
    18+
    Phase
    PHASE1/PHASE2
    Participants Needed
    512
    Est. Completion Date
    Apr 4, 2024
    Treatment Type
    INTERVENTIONAL

    Sponsor
    Bristol-Myers Squibb
    ClinicalTrials.gov NCT Identifier
    NCT03110107
    Study Number
    CA022001

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