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Trial ID CA224-034  |   NCT02966548

Safety Study of BMS-986016 With or Without Nivolumab in Patients With Advanced Solid Tumors

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Summary

  • Phase 1
  • Male and Female Gender icon
  • 20+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

This study will be used to determine the safety and tolerability of BMS-986016 administered alone and in combination with Nivolumab in subjects with advanced solid tumors.

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Key Eligibility Criteria

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

Inclusion Criteria

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:
  • Must have histologic or cytologic confirmation of an incurable solid malignancy that is advanced (metastatic and/or unresectable)
    1. Must have received, and then progressed or been intolerant to, standard treatment regimen in the advanced or metastatic setting, if such a therapy exists
      1. Presence of at least one lesion with measurable disease as defined by RECIST v1.1 criteria for response assessment
        1. Males and Females, ages 20 years or older, inclusive

          Exclusion Criteria

          Exclusion Criteria Icon
          :
          • Known or suspected CNS (central nervous system) metastases or with the CNS as the only site of active disease
            1. Other concomitant malignancies (with some exceptions per protocol)
              1. Any active autoimmune disease or history of known or suspected autoimmune disease
                1. History of uncontrolled or significant cardiovascular disease Other protocol defined inclusion/exclusion criteria could apply
                  Additional Information *

                  Treatment Options

                  Study Arms

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Combination Therapy

                  ASSIGNED INTERVENTION
                  • Drug: Relatlimab, Nivolumab

                  Study Arms

                  Experimental: Monotherapy

                  ASSIGNED INTERVENTION
                  • Drug: Relatlimab

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