Clinical Trials /

First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Patients With Advanced Solid Tumors

NCT03110107

Description:

The purpose of this study is to determine whether a Monoclonal Antibody 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: First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Patients With Advanced Solid Tumors
  • Official Title: Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination With Nivolumab in Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: CA022-001
  • SECONDARY ID: 2017-000597-11
  • NCT ID: NCT03110107

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
IpilimumabYervoyIpilimumab Monotherapy
BMS-986218BMS-986218 Monotherapy
NivolumabOpdivoCombination Therapy

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Ipilimumab MonotherapyExperimental
  • Ipilimumab
Combination TherapyExperimental
  • BMS-986218
  • Nivolumab
BMS-986218 MonotherapyExperimental
  • BMS-986218

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)

          -  Eastern Cooperative Oncology Group Performance Status of 0 or 1

          -  Participants must have received, and then progressed, relapsed, or been intolerant to
             at least 2 standard treatment regimens with proven survival benefit in the advanced or
             metastatic setting according to tumor type, if such a therapy exists

        Exclusion Criteria:

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

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

          -  Prior anti-cancer treatments such as chemotherapy, radiotherapy, hormonal, or
             immunotherapy (including anti-PD-1/PD-L1) are permitted

        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 (AEs)
Time Frame:Up to 4 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:ORR of BMS-986218 alone or in combination with Nivolumab
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:mDOR of BMS-986218 alone or in combination with Nivolumab
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:PFS of BMS-986218 alone or in combination with Nivolumab
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Incidence of anti-drug antibody (ADA) to BMS-986218
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Percentage of change from baseline in T-regulatory cells (Tregs)
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Maximum observed serum concentration (Cmax)
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Time of maximum observed concentration (Tmax)
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Area under the concentration-time curve from time zero to the time of the
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Area under the concentration-time curve in 1 dosing interval [AUC(TAU)]
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Trough observed serum concentration (Ctrough)
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Total body clearance (CLT)
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Average serum concentration over a dosing interval (AUC[TAU]/tau) at steady state (Css-avg)
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Ratio of an exposure measure at steady state to that after the first dose [exposure measure includes AUC[TAU] and Cmax (AI)]
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Terminal serum half-life if data permit (T-HALF)
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Observed concentration at the end of a dosing interval (Ctau)
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Time to deterioration (TTD) in Quality of Life and physical functioning
Time Frame:Up to 4 years
Safety Issue:
Description:

Details

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

Last Updated

November 4, 2020