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An Investigational Immunotherapy Study of BMS-986299 Alone and in Combination With Nivolumab and Ipilimumab in Participants With Solid Cancers That Have Spread or Cannot be Removed

NCT03444753

Description:

The purpose of this study is to determine whether BMS-986299 both by itself and in combination with Nivolumab and Ipilimumab is safe and tolerable in the treatment of advanced solid tumors. In addition, the ability of study drugs to stimulate an immune response against cancer will be investigated.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: An Investigational Immunotherapy Study of BMS-986299 Alone and in Combination With Nivolumab and Ipilimumab in Participants With Solid Cancers That Have Spread or Cannot be Removed
  • Official Title: A Phase I Study of BMS-986299 as Monotherapy and in Combination With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers

Clinical Trial IDs

  • ORG STUDY ID: CA039-001
  • NCT ID: NCT03444753

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
BMS-986299Arm A
NivolumabOpdivo, BMS-936558Arm B
IpilimumabYervoy, BMS-734016Arm B

Purpose

The purpose of this study is to determine whether BMS-986299 both by itself and in combination with Nivolumab and Ipilimumab is safe and tolerable in the treatment of advanced solid tumors. In addition, the ability of study drugs to stimulate an immune response against cancer will be investigated.

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentalBMS-986299
  • BMS-986299
Arm BExperimentalBMS-986299 in combination with nivolumab and ipilimumab
  • BMS-986299
  • Nivolumab
  • Ipilimumab

Eligibility Criteria

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

        Inclusion Criteria:

          -  Histologically or cytologically confirmed advanced/metastatic solid tumor and
             refractory to or intolerant of existing therapy(ies) known to provide clinical benefit
             for the condition of the participant

          -  IO therapy resistant or insensitive tumors

          -  Have at least 2 tumor lesions accessible for biopsy

          -  Eastern Cooperative Oncology Group Performance Status of 0 or 1

        Exclusion Criteria:

          -  Primary CNS malignancy

          -  Participants with other active malignancy requiring concurrent intervention

          -  Uncontrolled or significant cardiovascular disease

        Other protocol defined inclusion/exclusion criteria could apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of dose-limiting toxicities (DLTs)
Time Frame:Up to 28 days
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Maximum observed plasma concentration (Cmax)
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Time of maximum observed plasma concentration (Tmax)
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Area under the plasma concentration-time curve from time zero to 24 hours postdose [AUC(0-24)]
Time Frame:Approximately 2 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

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