Clinical Trials /

An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination With Nivolumab in Patients With Advanced Cancers

NCT03400332

Description:

The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab in patients with advanced cancers.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: An Investigational Immuno-Therapy Study of Experimental Medication BMS-986253 Given in Combination With Nivolumab in Patients With Advanced Cancers
  • Official Title: A Phase 1/2a Study of BMS-986253 in Combination With Nivolumab in Advanced Cancers

Clinical Trial IDs

  • ORG STUDY ID: CA027-002
  • NCT ID: NCT03400332

Conditions

  • Cancer

Interventions

DrugSynonymsArms
BMS-986253Dose Finding
NivolumabBMS-936558, OpdivoDose Finding

Purpose

The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab in patients with advanced cancers.

Trial Arms

NameTypeDescriptionInterventions
Dose FindingExperimentalBMS-986253 administered in combination with Nivolumab
  • BMS-986253
  • Nivolumab
Dose ExpansionExperimentalBMS-986253 administered in combination with Nivolumab
  • BMS-986253
  • Nivolumab

Eligibility Criteria

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

        Inclusion Criteria:

          -  Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic,
             recurrent and/or unresectable) with measurable disease per RECIST v1.1

          -  At least 1 lesion accessible for biopsy

          -  Eastern Cooperative Oncology Group Performance Status of 0 or 1

        Exclusion Criteria:

          -  Participants with CNS metastases as the only site of active disease (Participants with
             controlled brain metastases; however, will be allowed to enroll)

          -  Participants with active, known or suspected autoimmune disease

          -  Participants with conditions requiring systemic treatment with either corticosteroids
             (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days
             of study treatment administration

          -  Participants with a known history of testing positive for Human Immunodeficiency Virus
             (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)

          -  Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior
             anti-cancer therapy and initiation of study therapy

        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 adverse events (AE)
Time Frame:Approximately 5 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall response rate (ORR)
Time Frame:Approximately 5 years
Safety Issue:
Description:
Measure:Median duration of response (mDOR)
Time Frame:Approximately 5 years
Safety Issue:
Description:
Measure:Incidence of anti-drug antibody (ADA) to BMS-986253
Time Frame:Approximately 5 years
Safety Issue:
Description:
Measure:Serum biomarker concentration
Time Frame:Approximately 5 years
Safety Issue:
Description:
Measure:Maximum observed serum concentration (Cmax)
Time Frame:Approximately 5 years
Safety Issue:
Description:
Measure:Time of maximum observed serum concentration (Tmax)
Time Frame:Approximately 5 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 5 years
Safety Issue:
Description:
Measure:Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
Time Frame:Approximately 5 years
Safety Issue:
Description:
Measure:Observed serum concentration at the end of a dosing interval (Ctau)
Time Frame:Approximately 5 years
Safety Issue:
Description:
Measure:Trough observed serum concentration at the end of the dosing interval (Ctrough)
Time Frame:Approximately 5 years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

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