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An Investigational Immuno-therapy Study to Evaluate the Safety and Effectiveness of Experimental Medication BMS-986207 by Itself and in Combination With Nivolumab in Solid Cancers That Are Advanced or Have Spread

NCT02913313

Description:

The purpose of this study is to evaluate the safety and effectiveness of experimental medication BMS-986207 by itself and in combination with Nivolumab in solid cancers that are advanced or have spread.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: An Investigational Immuno-therapy Study to Evaluate the Safety and Effectiveness of Experimental Medication BMS-986207 by Itself and in Combination With Nivolumab in Solid Cancers That Are Advanced or Have Spread
  • Official Title: Phase 1/2a First-In-Human Study of BMS-986207 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: CA020-002
  • SECONDARY ID: 2016-002263-34
  • NCT ID: NCT02913313

Conditions

  • Broad Solid Tumor

Interventions

DrugSynonymsArms
BMS-986207Part 1A- Dose Escalation- Monotherapy
NivolumabBMS-936558, OpdivoPart 1B- Dose Escalation- Combination Therapy

Purpose

The purpose of this study is to evaluate the safety and effectiveness of experimental medication BMS-986207 by itself and in combination with Nivolumab in solid cancers that are advanced or have spread.

Trial Arms

NameTypeDescriptionInterventions
Part 1A- Dose Escalation- MonotherapyExperimentalSpecified dose on specified days
  • BMS-986207
Part 1B- Dose Escalation- Combination TherapyExperimentalSpecified dose on specified days
  • BMS-986207
  • Nivolumab
Part 2A- Expansion- MonotherapyExperimentalSpecified dose on specified days
  • BMS-986207
Part 2B- Expansion- Combination TherapyExperimentalSpecified dose on specified days
  • BMS-986207
  • Nivolumab

Eligibility Criteria

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

        Inclusion Criteria:

          -  Women and men ≥18 years of age with Eastern Cooperative Oncology Group (ECOG)
             performance status of 0 or 1

          -  Must have received and progressed on or failed one standard/approved treatment for
             cancer type, if available

          -  At least 4 weeks since any previous treatment for cancer

          -  Subject must consent to pretreatment and on treatment tumor biopsies

          -  At least one lesion with measurable disease at baseline

          -  Adequate organ and marrow function

        Exclusion Criteria:

          -  Patients with primary brain tumors or primary tumors with central nervous system
             metastases as only location of disease. Controlled brain metastases are permitted

          -  Prior organ transplant

          -  Participants with second/other active cancers requiring current treatment

          -  Uncontrolled/significant heart disease

          -  History of chronic hepatitis, Positive test for Hepatitis B virus surface antigen or
             Hepatitis C antibody (except participants with liver cancer) or Human Immunodeficiency
             Virus/Acquired Immunodeficiency Syndrome(HIV/AIDS)

          -  Active/uncontrolled autoimmune disease

          -  Active infection

        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 of BMS-986207
Time Frame:Up to 15 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Best Overall Response (BOR)
Time Frame:Up to 36 months
Safety Issue:
Description:
Measure:Objective Response Rate (ORR)
Time Frame:Up to 36 months
Safety Issue:
Description:
Measure:median Duration of Response (mDOR)
Time Frame:Up to 36 months
Safety Issue:
Description:
Measure:Progression Free Survival Rate (PFSR)
Time Frame:Up to 36 months
Safety Issue:
Description:
Measure:Maximum observed plasma concentration (Cmax) of BMS-986207
Time Frame:Up to 15 months
Safety Issue:
Description:
Measure:Time of maximum observed plasma concentration (Tmax) of BMS-986207
Time Frame:Up to 15 months
Safety Issue:
Description:
Measure:Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-t)] of BMS-986207
Time Frame:Up to 15 months
Safety Issue:
Description:
Measure:Trough observed plasma concentration (Ctrough) of BMS-986207
Time Frame:Up to 15 months
Safety Issue:
Description:Includes pre-dose concentrations [C0] and Ctau
Measure:Area under the concentration-time curve in one dosing interval [AUC(tau)] of BMS-986207
Time Frame:Up to 15 months
Safety Issue:
Description:
Measure:Total body clearance (CLT) of BMS-986207
Time Frame:Up to 15 months
Safety Issue:
Description:
Measure:Observed concentration at the end of a dosing interval (Ctau) of BMS-986207
Time Frame:Up to 15 months
Safety Issue:
Description:
Measure:Effective elimination half-life (T-HALFeff) of BMS-986207
Time Frame:Up to 15 months
Safety Issue:
Description:explains degree of accumulation observed for a specific exposure measure [exposure measure includes AUC(tau)] derived from serum concentration versus time data
Measure:Accumulation Index (AI) of BMS-986207
Time Frame:Up to 15 months
Safety Issue:
Description:Ratio of exposure measure at steady state to that after the first dose (exposure measure includes AUC[tau]) derived from serum concentration versus time data).
Measure:Average concentration of BMS-986207 over a dosing interval
Time Frame:Up to 15 months
Safety Issue:
Description:Css-avg= AUC[TAU]/tau
Measure:Immunogenicity measured by the occurrence of anti-drug antibody after the administration of BMS-986207
Time Frame:Up to 15 months
Safety Issue:
Description:
Measure:Immunogenicity measured by the occurrence of anti-drug antibody after the administration of BMS-986207 in combination with nivolumab (BMS-936558)
Time Frame:Up to 15 months
Safety Issue:
Description:
Measure:Tumor infiltrating lymphocyte (TIL) evaluations for BMS-986207
Time Frame:Up to 6 months
Safety Issue:
Description:This is how the pharmacodynamic activity will be measured
Measure:Serum cytokines profiling for BMS-986207
Time Frame:Up to 6 months
Safety Issue:
Description:This is how the pharmacodynamic activity will be measured
Measure:Serum proteome analysis for BMS-986207
Time Frame:Up to 6 months
Safety Issue:
Description:This is how the pharmacodynamic activity will be measured
Measure:Flow-cytometry evaluation of circulating immune cell subsets for BMS-986207
Time Frame:Up to 6 months
Safety Issue:
Description:This is how the pharmacodynamic activity will be measured
Measure:Tumor-specific immune cells for BMS-986207
Time Frame:Up to 6 months
Safety Issue:
Description:This is how the pharmacodynamic activity will be measured
Measure:Tumor infiltrating lymphocyte (TIL) evaluations for BMS-986207 in combination with nivolumab (BMS-936558)
Time Frame:Up to 6 months
Safety Issue:
Description:This is how the pharmacodynamic activity will be measured
Measure:Serum cytokines profiling for BMS-986207 in combination with nivolumab (BMS-936558)
Time Frame:Up to 6 months
Safety Issue:
Description:This is how the pharmacodynamic activity will be measured
Measure:Serum proteome analysis for BMS-986207 in combination with nivolumab(BMS-936558)
Time Frame:Up to 6 months
Safety Issue:
Description:This is how the pharmacodynamic activity will be measured
Measure:Flow-cytometry evaluation of circulating immune cell subsets for BMS-986207 in combination with nivolumab (BMS-936558)
Time Frame:Up to 6 months
Safety Issue:
Description:This is how the pharmacodynamic activity will be measured
Measure:Tumor-specific immune cells for BMS-986207 in combination with nivolumab(BMS-936558)
Time Frame:Up to 6 months
Safety Issue:
Description:This is how the pharmacodynamic activity will be measured

Details

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

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