Clinical Trials /

An Investigational Immunotherapy Study of BMS-986249 Alone and in Combination With Nivolumab in Solid Cancers That Are Advanced or Have Spread

NCT03369223

Description:

The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: An Investigational Immunotherapy Study of BMS-986249 Alone and in Combination With Nivolumab in Solid Cancers That Are Advanced or Have Spread
  • Official Title: A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: CA030-001
  • SECONDARY ID: 2018-000416-21
  • NCT ID: NCT03369223

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
BMS-986249Part 1A
NivolumabOpdivo, BMS-936558Part 1B
IpilimumabYervoy, BMS 734016Part 2A Arm D

Purpose

The purpose of this study is to determine whether BMS-986249 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors

Trial Arms

NameTypeDescriptionInterventions
Part 1AExperimentalBMS-986249 alone
  • BMS-986249
Part 1BExperimentalBMS-986249 in combination with nivolumab
  • BMS-986249
  • Nivolumab
Part 2A Arm AExperimentalBMS-986249 in combination with nivolumab followed by nivolumab monotherapy
  • BMS-986249
  • Nivolumab
Part 2A Arm BExperimentalBMS-986249 in combination with nivolumab followed by nivolumab monotherapy
  • BMS-986249
  • Nivolumab
Part 2A Arm CExperimentalBMS-986249 in combination with nivolumab
  • BMS-986249
  • Nivolumab
Part 2A Arm DExperimentalIpilimumab in combination with nivolumab followed by nivolumab monotherapy
  • Nivolumab
  • Ipilimumab
Part 2A Arm EExperimentalNivolumab monotherapy
  • 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 and have at least 1 lesion
             accessible for biopsy

          -  Eastern Cooperative Oncology Group Performance Status of 0 or 1

          -  Some participants must have received, and then progressed, relapsed, or been
             intolerant to, at least 1 standard treatment regimen in the advanced or metastatic
             setting according to solid tumor histologies

          -  Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are
             permitted for some patients

          -  Understand and sign an IRB/IEC-approved ICF prior to any study-specific evaluation

          -  Willing and able to comply with all study procedures

        Exclusion Criteria:

          -  Participants with primary CNS malignancies, tumors with CNS metastases as the only
             site of disease, active brain metastases, or leptomeningeal metastasis will be
             excluded

          -  Active, known, or suspected autoimmune disease

          -  Participants with other active malignancy requiring concurrent intervention

        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:up to 2.5 years
Safety Issue:
Description:Safety and tolerability as measured by incidence of AEs Applies to Part 1

Secondary Outcome Measures

Measure:Cmax (Maximum observed serum concentration) of BMS-986249
Time Frame:up to 2 years
Safety Issue:
Description:Applies to Part 1 and Part 2A
Measure:Tmax (Time of maximum observed concentration) of BMS-986249
Time Frame:up to 2 years
Safety Issue:
Description:Applies to Part 1 and Part 2A
Measure:AUC(0-T) (Area under the serum concentration-time curve from time zero to time of last quantifiable concentration) of BMS-986249
Time Frame:up to 2 years
Safety Issue:
Description:Applies to Part 1 and Part 2A
Measure:AUC(TAU) (Area under the concentration-time curve in 1 dosing interval) of BMS-986249
Time Frame:up to 2 years
Safety Issue:
Description:Applies to Part 1 and Part 2A
Measure:Ctau (Observed concentration at the end of a dosing interval) of BMS-986249
Time Frame:up to 2 years
Safety Issue:
Description:Applies to Part 1 and Part 2A
Measure:Ctrough (Trough observed concentrations) of BMS-986249
Time Frame:up to 2 years
Safety Issue:
Description:Applies to Part 1 and Part 2A
Measure:Objective Response Rate (ORR)
Time Frame:up to 4 years
Safety Issue:
Description:Assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measure:Duration of response (DOR)
Time Frame:up to 4 years
Safety Issue:
Description:Assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measure:Progression-Free survival (PFS)
Time Frame:up to 4 years
Safety Issue:
Description:Assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measure:Time to response (TTR)
Time Frame:up to 4 years
Safety Issue:
Description:Assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measure:Total body clearance (CLT) of BMS-986249
Time Frame:up to 2 years
Safety Issue:
Description:Applies to Part 1
Measure:Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg) of BMS-986249
Time Frame:up to 2 years
Safety Issue:
Description:Applies to Part 1
Measure:Terminal serum half-life if data permit (T-HALF) of BMS-986249
Time Frame:up to 2 years
Safety Issue:
Description:Applies to Part 1
Measure:Ratio of an exposure measure at steady state to that after the first dose [exposure measure includes AUC[TAU] and Cmax (AI)] of BMS-986249
Time Frame:up to 2 years
Safety Issue:
Description:Applies to Part 1
Measure:Incidence of Adverse Events (AE)
Time Frame:up to 2.5 years
Safety Issue:
Description:Applies to Part 2A
Measure:Incidence of Serious Adverse Events (SAEs)
Time Frame:up to 2.5 years
Safety Issue:
Description:Applies to Part 2A
Measure:Incidence of AEs leading to discontinuation
Time Frame:up to 2.5 years
Safety Issue:
Description:Applies to Part 2A
Measure:Incidence of Deaths
Time Frame:up to 2.5 years
Safety Issue:
Description:Applies to Part 2A
Measure:Incidence of laboratory abnormalities
Time Frame:up to 4 years
Safety Issue:
Description:Applies to Part 2A

Details

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

Trial Keywords

  • Antibodies
  • Antineoplastic Agents
  • Immunologic Factors
  • Nivolumab
  • Antibodies, Monoclonal
  • Physiological Effects of Drugs

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