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An Investigational Immuno-Therapy Study of Experimental Medication BMS-986277 Given Alone and in Combination With Nivolumab in Epithelial Cancers

NCT03363776

Description:

The purpose of this study is to investigate experimental medication BMS-986277 given alone and in combination with Nivolumab in patients with epithelial cancers.

Related Conditions:
  • Breast Carcinoma
  • Colorectal Carcinoma
  • Ovarian Carcinoma
  • Pancreatic Carcinoma
  • Prostate Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: An Investigational Immuno-Therapy Study of Experimental Medication BMS-986277 Given Alone and in Combination With Nivolumab in Epithelial Cancers
  • Official Title: Phase 1/2a First in Human Study of BMS-986277 Administered Alone and in Combination With Nivolumab in Advanced Epithelial Tumors

Clinical Trial IDs

  • ORG STUDY ID: CA034-001
  • SECONDARY ID: 2017-002199-24
  • NCT ID: NCT03363776

Conditions

  • Cancer

Interventions

DrugSynonymsArms
BMS-986277Monotherapy
NivolumabOpdivo, BMS-963558Combination Dose Escalation Therapy

Purpose

The purpose of this study is to investigate experimental medication BMS-986277 given alone and in combination with Nivolumab in patients with epithelial cancers.

Trial Arms

NameTypeDescriptionInterventions
MonotherapyExperimentalBMS-986277 administered alone
  • BMS-986277
Combination Dose Escalation TherapyExperimentalBMS-986277 administered in combination with Nivolumab
  • BMS-986277
  • Nivolumab
Combination Expansion TherapyExperimentalBMS-986277 monotherapy with option for subsequent Nivolumab therapy
  • BMS-986277
  • Nivolumab

Eligibility Criteria

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

        Inclusion Criteria:

          -  Histological or cytological confirmation of metastatic and/or unresectable metastatic
             colorectal, prostate, pancreatic, breast, ovarian, or urothelial carcinoma with
             measureable disease for solid tumors per RECIST v1.1 and for prostate carcinoma per
             PCWG3

          -  Presence of at least 2 lesions: at least one with measurable disease as defined by
             RECIST v1.1 for solid tumors and by PCWG3 for prostate carcinoma for response
             assessment; at least 1 lesion must be accessible for biopsy in addition to the target
             lesion

          -  Participants must have received, and then progressed or been intolerant to, at least 1
             standard treatment regimen in the advanced or metastatic setting, if such a therapy
             exists, and have been considered for all other potentially efficacious therapies prior
             to enrollment

          -  ECOG performance status less than or equal to 2

        Exclusion Criteria:

          -  Participants with active central nervous system (CNS) metastases, untreated CNS
             metastases, or with the CNS as the only site of disease

          -  Participants with carcinomatous meningitis

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

          -  Participants with active, known, or suspected autoimmune 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 adverse events (AE)
Time Frame:Up to 842 days
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:24 weeks
Safety Issue:
Description:
Measure:Disease control rate (DCR)
Time Frame:24 weeks
Safety Issue:
Description:
Measure:Median duration of response (mDOR)
Time Frame:Up to 2 years
Safety Issue:
Description:
Measure:Median progression-free survival (mPFS)
Time Frame:Up to 24 weeks
Safety Issue:
Description:
Measure:Progression-free survival (PFS)
Time Frame:Up to 24 weeks
Safety Issue:
Description:
Measure:Maximum observed blood concentration (Cmax)
Time Frame:Up to 92 days
Safety Issue:
Description:
Measure:Time of maximum observed blood concentration (Tmax)
Time Frame:Up to 92 days
Safety Issue:
Description:
Measure:Area under the blood concentration-time curve from time zero to time of last quanitifiable concentration [AUC(0-T)]
Time Frame:Up to 92 days
Safety Issue:
Description:
Measure:Area under the blood concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time Frame:Up to 92 days
Safety Issue:
Description:
Measure:Apparent terminal half-life (T-HALF)
Time Frame:Up to 92 days
Safety Issue:
Description:
Measure:Total body clearance (CLT)
Time Frame:Up to 92 days
Safety Issue:
Description:
Measure:Volume of distribution at steady-state (Vss)
Time Frame:Up to 92 days
Safety Issue:
Description:
Measure:Volume of distribution of the elimination phase (Vz)
Time Frame:Up to 92 days
Safety Issue:
Description:
Measure:Average plasma concentration over a dosing interval (AUC[0-48]/48) (Css-avg)
Time Frame:Up to 92 days
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Bristol-Myers Squibb

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