Clinical Trials /

An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers

NCT03956680

Description:

The main purpose of this study is to characterize the safety, tolerability, dose limiting toxicities, maximum tolerated dose, maximum administered dose, or alternative dose of BMS-986301 alone or in combination with nivolumab and ipilimumab to participants with cancers that have failed to respond to or are known to be insensitive to T cell checkpoint inhibiting antibodies.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: An Investigational Immunotherapy Study of BMS-986301 Alone or in Combination With Nivolumab, and Ipilimumab in Participants With Advanced Solid Cancers
  • Official Title: A Phase I Study of BMS-986301 Monotherapy and Combination Therapy With Nivolumab and Ipilimumab in Participants With Advanced Solid Cancers

Clinical Trial IDs

  • ORG STUDY ID: CA046-006
  • SECONDARY ID: 2018-003610-41
  • NCT ID: NCT03956680

Conditions

  • Advanced Solid Cancers

Interventions

DrugSynonymsArms
BMS-986301BMS-986301 followed by Nivolumab and Ipilimumab therapy
NivolumabBMS-986301 followed by Nivolumab and Ipilimumab therapy
IpilimumabBMS-986301 followed by Nivolumab and Ipilimumab therapy

Purpose

The main purpose of this study is to characterize the safety, tolerability, dose limiting toxicities, maximum tolerated dose, maximum administered dose, or alternative dose of BMS-986301 alone or in combination with nivolumab and ipilimumab to participants with cancers that have failed to respond to or are known to be insensitive to T cell checkpoint inhibiting antibodies.

Trial Arms

NameTypeDescriptionInterventions
BMS-986301 followed by Nivolumab and Ipilimumab therapyExperimental
  • BMS-986301
  • Nivolumab
  • Ipilimumab

Eligibility Criteria

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

        Inclusion Criteria:

          -  Histologically or cytologically confirmed advanced/metastatic solid tumor and
             refractory to or intolerant of existing therapy(ies) known to provide clinical benefit
             for the condition of the participant

          -  IO therapy resistant or insensitive tumors

          -  Have at least 1 (intramuscular treatment group) or 2 (intratumoral treatment group)
             tumor lesions accessible for biopsy

          -  Eastern Cooperative Oncology Group Performance Status of 0 or 1

        Exclusion Criteria:

          -  Primary central nervous system malignancy

          -  Participants with other active malignancy requiring concurrent intervention

          -  Uncontrolled or significant cardiovascular disease

        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:Number of Participants With Dose-Limiting Toxicities (DLTs)
Time Frame:Cycle 1 (28 days)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Maximum Observed Plasma Concentration (Cmax) of BMS-986301
Time Frame:approximately 2 years
Safety Issue:
Description:
Measure:Time to Reach Maximum Observed Plasma Concentration (Tmax) of BMS-986301
Time Frame:approximately 2 years
Safety Issue:
Description:
Measure:Area under the concentration-time curve in one dosing interval (24 h) of BMS-986301
Time Frame:Up to 24 hours
Safety Issue:
Description:
Measure:Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of BMS-986301
Time Frame:approximately 2 years
Safety Issue:
Description:
Measure:Changes in Levels and Activation of Tumor Infiltrating T Cells
Time Frame:approximately 2 years
Safety Issue:
Description:
Measure:Change in Programmed Death-Ligand 1 (PD-L1) Expression Status in Tumors
Time Frame:approximately 2 years
Safety Issue:
Description:
Measure:BMS-986301-induced Changes in Cytokines in Blood and Tumors
Time Frame:approximately 2 years
Safety Issue:
Description:

Details

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

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