Clinical Trials /

An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers

NCT03994601

Description:

The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select 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-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers
  • Official Title: A Phase 1/2 First-in-human Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Malignant Tumors

Clinical Trial IDs

  • ORG STUDY ID: CA043-001
  • NCT ID: NCT03994601

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
BMS-986288Arm A BMS-986288
NivolumabOpdivo/BMS 936558Arm B BMS-986288 in combination with Nivolumab

Purpose

The purpose of this study is to determine whether BMS-986288 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of select advanced solid tumors

Trial Arms

NameTypeDescriptionInterventions
Arm A BMS-986288ExperimentalSpecified dose on specified days
  • BMS-986288
Arm B BMS-986288 in combination with NivolumabExperimentalSpecified dose on specified days
  • BMS-986288
  • 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 select 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

          -  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 select solid tumor histologies

        Exclusion Criteria:

          -  Participants with active, known or suspected autoimmune disease

          -  Participants with other active malignancy requiring concurrent intervention

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

        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), Serious Adverse Events (SAEs), AEs meeting protocol-defined Dose Limiting Toxicities (DLT) Criteria, AEs leading to discontinuation, death and laboratory abnormalities
Time Frame:Up to 2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Maximum Observed Concentration (Cmax) of BMS-986288
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Time of Maximum Observed Concentration (Tmax) of BMS-986288
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Area Under the Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) of BMS-986288
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Area Under the Concentration-Time Curve in one Dosing Interval AUC(TAU) of BMS-986288
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Observed Concentration at the end of a Dosing Interval (Ctau) of BMS-986288
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Trough Observed Concentrations (Ctrough) of BMS-986288
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Total Body Clearance (CLT) of BMS-986288
Time Frame:Up to 4 months
Safety Issue:
Description:
Measure:Average Concentration Over a Dosing Interval at Steady State (Cavgss) of BMS-986288
Time Frame:Up to 4 months
Safety Issue:
Description:
Measure:Accumulation Index (AI) of BMS-986288
Time Frame:Up to 4 months
Safety Issue:
Description:
Measure:Terminal Half-Life (T-HALF) of BMS-986288
Time Frame:Up to 4 months
Safety Issue:
Description:
Measure:Incidence of Anti-Drug Antibodies (ADAs) to BMS-986288
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Objective Response Rate (ORR) of Participants
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Duration of Response (DOR) of Participants
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Progression-Free Survival (PFS) of Participants
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Time to Response (TTR) of Participants
Time Frame:Up to 4 years
Safety Issue:
Description:
Measure:Percentage of change from baseline in T-regulatory cells (Tregs)
Time Frame:Up to 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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