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A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors

NCT03251924

Description:

The purpose of this study is to investigate BMS-986226 administered alone or in combination with nivolumab or ipilimumab.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors
  • Official Title: A Phase 1/2 Dose Escalation and Combination Cohort Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Efficacy of BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: CA021-002
  • SECONDARY ID: 2017-000238-73
  • NCT ID: NCT03251924

Conditions

  • Cancer
  • Tumors
  • Neoplasm
  • Malignancy

Interventions

DrugSynonymsArms
BMS-986226BMS-986226
NivolumabBMS-936558, PD-1 receptor blocking monoclonal antibody [mAb], OpdivoBMS-986226 and Nivolumab
IpilimumabBMS-734016, MDX010, Checkpoint blocking antibody that recognizes CTLA-4, YervoyBMS-986226 and Ipilimumab

Purpose

The purpose of this study is to investigate BMS-986226 administered alone or in combination with nivolumab or ipilimumab.

Trial Arms

NameTypeDescriptionInterventions
BMS-986226Experimentaladministered intravenously
  • BMS-986226
BMS-986226 and NivolumabExperimentaladministered intravenously
  • BMS-986226
  • Nivolumab
BMS-986226 and IpilimumabExperimentaladministered intravenously
  • BMS-986226
  • Ipilimumab

Eligibility Criteria

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

        Inclusion Criteria:

          -  Advanced solid tumors

          -  Histological or cytological confirmation of a malignancy that is advanced (metastatic
             and/or unresectable) with measureable disease as defined by Response Evaluation
             Criteria In Solid Tumors (RECIST) v1.1

          -  At least 1 lesion accessible for biopsy in addition to the target lesion

          -  Participants must have received, and then progressed or been intolerant to, at least 1
             standard treatment regimen

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤2

        Exclusion Criteria:

          -  Participants with active central nervous system (CNS) metastases, untreated CNS
             metastases, or with the CNS as the only site of disease are excluded (controlled brain
             metastases will be allowed to enroll)

          -  Participants with carcinomatous meningitis

          -  Prior malignancy active within the previous 2 years except for locally curable cancers
             that have been apparently cured, such as basal or squamous cell skin cancer,
             superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast

          -  Active, known, or suspected autoimmune disease

          -  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 adverse events (AE)
Time Frame:Approximately 2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective response rate (ORR) measure by Clopper-Pearson method
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Median Duration of Response (mDOR) measured by Kaplan-Meier method
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Progression Free Survival (PFS) measured by Kaplan-Meier method
Time Frame:At 24 weeks
Safety Issue:
Description:
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 concentration-time curve from time 0 to the time of the last [AUC (0-T)]
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Area under the concentration-time curve in 1 dosing interval [AUC(TAU)]
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Incidence of anti-drug antibodies to BMS-986226 assessed by immunoassay
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Change from baseline in immunoassay for BMS-986226
Time Frame:Approximately 2 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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