Clinical Trials /

An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread

NCT02658890

Description:

The purpose of the study is to determine safety and effectiveness of experimental medication BMS-986205 when combined with Nivolumab and in combination with both Nivolumab and Ipilimumab in patients with cancers that are advanced or have spread. Pharmacokinetics and pharmacodynamics of BMS-986205 when combined with Nivolumab and in combination with Nivolumab and Ipilimumab in this patient population will also be assessed.

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 BMS-986205 Given in Combination With Nivolumab in Cancers That Are Advanced or Have Spread.
  • Official Title: A Phase 1/2a Study of BMS-986205 Administered in Combination With Nivolumab (BMS-936558, Anti-PD-1 Monoclonal Antibody) in Advanced Malignant Tumors

Clinical Trial IDs

  • ORG STUDY ID: CA017-003
  • SECONDARY ID: 2015-004914-79
  • NCT ID: NCT02658890

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
BMS-986205Combination Therapy (Dose Escalation)
NivolumabCombination Therapy (Dose Escalation)

Purpose

The purpose of the study is to determine the safety and effectiveness of experimental medication BMS-986205, when combined with Nivolumab in patients with cancers that are advanced or have spread.

Trial Arms

NameTypeDescriptionInterventions
Combination Therapy (Dose Escalation)ExperimentalBMS 986205 + Nivolumab specified dose at specified intervals.
  • BMS-986205
  • Nivolumab
Combination Therapy (Dose Expansion)ExperimentalBMS 986205 + Nivolumab specified dose at specified intervals.
  • BMS-986205
  • Nivolumab

Eligibility Criteria

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

        Inclusion Criteria:

          -  Patients must have been diagnosed with cancer and had at least 1 prior standard
             treatment

          -  Must be able to swallow pills or capsules

          -  Eastern Cooperative Oncology Group(ECOG) Performance Status 0-1

        Exclusion Criteria:

          -  Any prior ongoing clinical study with Nivolumab with overall survival as an endpoint

          -  Requirement for daily supplemental oxygen

          -  Myocardial infarction or stroke/transient ischemic attack within the past 6 months

          -  Uncontrolled angina within the past 3 months

          -  History of any chronic Hepatitis, active Hepatitis B or C, human immunodeficiency
             virus(HIV), or acquired immune deficiency syndrome(AIDS)

        Other protocol defined inclusion/exclusion criteria could apply
      
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety of BMS-986205 as measured by incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, deaths, and clinical laboratory test abnormalities.
Time Frame:100 days after the last dose of study therapy
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Maximum observed plasma concentration (Cmax) of BMS-986205
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Time of maximum observed plasma concentration (Tmax) of BMS-986205
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986205
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of BMS-986205
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Area under the concentration-time curve in 1 dosing interval [AUC(TAU)] of BMS-986205
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Trough observed plasma concentration at the end of the dosing interval (Ctrough) of BMS-986205
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Observed plasma concentration at 24 hours (C24) of BMS-986205
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Apparent terminal phase half-life (T-HALF) of BMS-986205
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Apparent total body clearance (CLT/F) of BMS-986205
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Apparent renal clearance (CLR/F) of BMS-986205
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Volume of distribution of terminal phase (Vz/F) of BMS-986205
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Apparent volume of distribution at steady state (Vss/F) of BMS-986205
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Accumulation index (AI) of BMS-986205
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Percent urinary recovery (%UR) of BMS-986205
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Percent urinary recovery over 24 hours(%UR24) of BMS-986205
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) of BMS-986205
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Ratio of metabolite AUC(0-T) to parent AUC(0-T), corrected for molecular weight (single dose in clinical pharmacology substudy only) [MR_AUC(0-T)] of BMS-986205
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)] of BMS-986205
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Ratio of metabolite AUC(INF) to parent AUC(INF), corrected for molecular weight (single dose in clinical pharmacology substudy only) [MR_AUC(INF)] of BMS-986205
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Anti-drug antibody (ADA) response to Nivolumab in combination with BMS-986205
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Objective response rate (ORR)
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Progression free survival rate (PFSR)
Time Frame:Approximately 3 years
Safety Issue:
Description:
Measure:Duration of response(DOR)
Time Frame:Approximately 3 years
Safety Issue:
Description:

Details

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

Last Updated

March 6, 2017