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An Investigational Immuno-therapy Study of Experimental Medication BMS-986178 by Itself or in Combination With Nivolumab and/or Ipilimumab in Patients With Solid Cancers That Are Advanced or Have Spread

NCT02737475

Description:

The purpose of the study is to determine the safety and tumor-shrinking ability of experimental medication BMS-986178, when given by itself or in combination with Nivolumab and/or Ipilimumab, in patients with solid cancers that are advanced or have spread.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: An Investigational Immuno-therapy Study of Experimental Medication BMS-986178 by Itself or in Combination With Nivolumab and/or Ipilimumab in Patients With Solid Cancers That Are Advanced or Have Spread
  • Official Title: A Phase 1/2a Study of BMS-986178 Administered Alone and in Combination With Nivolumab and/or Ipilimumab in Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: CA012-004
  • SECONDARY ID: 2015-004816-39
  • NCT ID: NCT02737475

Conditions

  • Advanced Cancer

Interventions

DrugSynonymsArms
BMS-986178Part 1: Dose Escalation
NivolumabBMS-936558, OpdivoPart 2: Dose Escalation and Expansion
IpilimumabBMS-734016, YervoyPart 3: Dose Escalation and Expansion

Purpose

The purpose of the study is to determine the safety and tumor-shrinking ability of experimental medication BMS-986178, when given by itself or in combination with Nivolumab and/or Ipilimumab, in patients with solid cancers that are advanced or have spread.

Trial Arms

NameTypeDescriptionInterventions
Part 1: Dose EscalationExperimentalBMS-986178 at specified doses at specified intervals
  • BMS-986178
Part 2: Dose Escalation and ExpansionExperimentalBMS-986178 in combination with Nivolumab at specified doses at specified intervals
  • BMS-986178
  • Nivolumab
Part 3: Dose Escalation and ExpansionExperimentalBMS-986178 in combination with Ipilimumab at specified doses at specified intervals
  • BMS-986178
  • Ipilimumab
Part 4: Dose Schedule and ExplorationExperimentalBMS-986178/Nivolumab at specified doses at specified intervals
  • BMS-986178
  • Nivolumab
Part 5: Dose Schedule and ExplorationExperimentalBMS-986178/Ipilimumab at specified doses at specified intervals
  • BMS-986178
  • Ipilimumab
Part 6: Dose Safety and ExpansionExperimentalBMS-986178/Ipilimumab/Nivolumab at specified doses at specified intervals
  • BMS-986178
  • Nivolumab
  • Ipilimumab
Part 7: Dose Safety and ExpansionExperimentalBMS-986178/Ipilimumab/Nivolumab at specified doses at specified intervals
  • BMS-986178
  • Nivolumab
  • Ipilimumab
Part 8: Dose Schedule and ExplorationExperimentalBMS-986178/Nivolumab with tetanus vaccine at specified doses and interval
  • BMS-986178
  • Nivolumab

Eligibility Criteria

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

        Inclusion Criteria:

          -  Patients must have at least 1 standard treatment regimen in the advanced, recurrent or
             metastatic setting

          -  ECOG (Eastern Cooperative Oncology Group) 0-1

          -  Men and women 18 years old or older

          -  At least one measurable lesion at baseline by CT (computed tomography) or MRI
             (magnetic resonance imaging) as per RECIST (Response Evaluation Criteria In Solid
             Tumors) v1.1

          -  All subjects must have a fresh tumor biopsy

        Exclusion Criteria:

          -  Known central nervous system metastases or central nervous system as the only source
             of disease

          -  Concomitant malignancies

          -  Active known or suspected autoimmune disease

          -  Uncontrolled or significant cardiovascular disease

          -  Major surgery less than 4 weeks before the start of the study

          -  Patients with known allergies to egg products, neomycin, or tetanus toxoid

          -  Prior adverse reaction to tetanus toxoid-containing vaccines

        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 AE's (adverse events) and SAE's (serious adverse events), AE's leading to discontinuation, deaths and clinical laboratory test abnormalities
Time Frame:Approximately 4 years.
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Cmax (maximum observed serum concentration) for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits
Time Frame:Approximately 100 days after the final study drug administration (end of treatment)
Safety Issue:
Description:
Measure:Tmax (time of maximum observed concentration) for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits
Time Frame:Approximately 100 days after the final study drug administration (end of treatment)
Safety Issue:
Description:
Measure:AUC(0-t) (area under the concentration-time curve from time zero to the time) for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits
Time Frame:Approximately 100 days after the final study drug administration (end of treatment)
Safety Issue:
Description:
Measure:AUC(TAU) (area under the concentration-time curve in 1 dosing interval) for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits
Time Frame:Approximately 100 days after the final study drug administration (end of treatment)
Safety Issue:
Description:
Measure:Ctau (the observed concentration at the end of a dosing interval) for BMS- 986178 alone and in combination with nivolumab and/or ipilimumab, if data permits
Time Frame:Approximately 100 days after the final study drug administration (end of treatment)
Safety Issue:
Description:
Measure:CLT (total body clearance) for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits
Time Frame:Approximately 100 days after the final study drug administration (end of treatment)
Safety Issue:
Description:
Measure:Css-avg [average concentration over a dosing interval (AUC(TAU)/tau)] for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits
Time Frame:Approximately 100 days after the final study drug administration (end of treatment)
Safety Issue:
Description:
Measure:AI [ratio of an exposure measure at steady state to that after the first dose (exposure measure includes AUC(TAU), Cmax and Ctau)] for BMS- 986178 alone and in combination with nivolumab and/or ipilimumab, if data permits
Time Frame:Approximately 100 days after the final study drug administration (end of treatment)
Safety Issue:
Description:
Measure:T-HALFeff [effective elimination half-life to explain degree of accumulation for a specific exposure measure (exposure measure includes AUC(TAU), Cmax and Ctau)] for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits
Time Frame:Approximately 100 days after the final study drug administration (end of treatment)
Safety Issue:
Description:
Measure:Ctrough [trough observed plasma concentrations (this includes pre-dose concentrations (C0) and Ctau)] for BMS-986178 alone and in combination with nivolumab and/or ipilimumab, if data permits
Time Frame:Approximately 100 days after the final study drug administration (end of treatment)
Safety Issue:
Description:
Measure:Immunoassay of anti-nivolumab antibody in combination with anti-BMS- 986178 antibody
Time Frame:Approximately 100 days after the final study drug administration (end of treatment)
Safety Issue:
Description:
Measure:Immunoassay of anti-ipilimumab antibody in combination with anti-BMS-986178 antibody
Time Frame:Approximately 100 days after the final study drug administration (end of treatment)
Safety Issue:
Description:
Measure:Objective Response Rate (ORR)
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Progression Free Survival Rate (PFSR)
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Immunoassay of anti-BMS-986178 antibody alone
Time Frame:Approximately 100 days after 6 months of treatment
Safety Issue:
Description:
Measure:Number of participants showing a change in one of the pharmacodynamic biomarkers of BMS-986178 administered in combination with nivolumab
Time Frame:Approximately 18 months
Safety Issue:
Description:

Details

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

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