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Phase I-II

A Phase 1/2 Study of BMS-986449 Alone and in Combination With Nivolumab in Participants With Advanced Solid Tumors

  • Study HIC#:2000035046
  • Last Updated:04/17/2024

The purpose of this study is to evaluate the safety and efficacy of BMS-986449 alone and in combination with nivolumab in participants with advanced solid tumors.

    Contact Us

    For more information about this study, including how to volunteer, contact:

    Ingrid Palma

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    You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.

    Eligibility Criteria

    Inclusion Criteria:

    • All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy (measurable by Response Evaluation Criteria in Solid Tumors [RECIST] v1.1), and have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant.

      • Part 1A may have a solid malignancy of any histology.
      • Part 1B is restricted to participants with Non-small cell lung cancer (NSCLC).
      • Part 1C is restricted to participants with Triple-negative breast cancer (TNBC).
    • Tumor biopsy must be obtained for all participants (unless medically precluded).

    Exclusion Criteria:

    • History of Grade ≥ 3 toxicity related to prior T-cell agonist or checkpoint inhibitor therapy (eg, anti-cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], or anti-PD- 1/programmed death-ligand 1 [PD-L1] treatment, or any other antibody or drug specifically targeting T-cell co-stimulation or other immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures.
    • Current or recent (within 3 months of study intervention administration) gastrointestinal disease or gastrointestinal surgery (eg, intestinal/gastric/colon resection) that could impact the absorption of study intervention.
    • Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.

    Other protocol-defined criteria may apply.

    Principal Investigator

    Sub-Investigators

    For more information about this study, including how to volunteer, contact: