Clinical Trials /

A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

NCT03400332

Description:

The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
  • Official Title: A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

Clinical Trial IDs

  • ORG STUDY ID: CA027-002
  • SECONDARY ID: 2018-000340-26
  • NCT ID: NCT03400332

Conditions

  • Cancer

Interventions

DrugSynonymsArms
BMS-986253Part 1A: BMS-986253 + nivolumab
NivolumabBMS-936558, OpdivoPart 1A: BMS-986253 + nivolumab
IpilimumabBMS-734016, YERVOYPart 1C: BMS-986253 + nivolumab + ipilimumab

Purpose

The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.

Trial Arms

NameTypeDescriptionInterventions
Part 1A: BMS-986253 + nivolumabExperimental
  • BMS-986253
  • Nivolumab
Part 1B: BMS-986253 + nivolumabExperimental
  • BMS-986253
  • Nivolumab
Part 1C: BMS-986253 + nivolumab + ipilimumabExperimental
  • BMS-986253
  • Nivolumab
  • Ipilimumab
Part 2A: BMS-986253 + nivolumab + ipilimumabExperimental
  • BMS-986253
  • Nivolumab
  • Ipilimumab
Part 2B: Placebo + nivolumab + ipilimumabPlacebo Comparator
  • Nivolumab
  • Ipilimumab

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) with measurable disease per RECIST v1.1

          -  At least 1 lesion accessible for biopsy

          -  Eastern Cooperative Oncology Group Performance Status of 0 or 1

        Exclusion Criteria:

          -  Participants with CNS metastases as the only site of active disease (Participants with
             controlled brain metastases; however, will be allowed to enroll)

          -  Participants with active, known or suspected autoimmune disease

          -  Participants with conditions requiring systemic treatment with either corticosteroids
             (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days
             of study treatment administration

          -  Participants with a known history of testing positive for Human Immunodeficiency Virus
             (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)

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

        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 (AE)
Time Frame:Approximately 5 years
Safety Issue:
Description:Part 1

Secondary Outcome Measures

Measure:Objective response rate (ORR) based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame:Approximately 5 years
Safety Issue:
Description:Part 1 and Part 2
Measure:Median duration of response (mDOR) per response evaluation criteria in solid tumors (RECIST) v1.1
Time Frame:Approximately 5 years
Safety Issue:
Description:Part 1
Measure:Incidence of anti-drug antibody (ADA) to BMS-986253
Time Frame:Approximately 5 years
Safety Issue:
Description:Part 1 and Part 2
Measure:Serum biomarker concentration
Time Frame:Approximately 5 years
Safety Issue:
Description:Part 1
Measure:Maximum observed serum concentration (Cmax)
Time Frame:Approximately 5 years
Safety Issue:
Description:Part 1 and Part 2
Measure:Time of maximum observed serum concentration (Tmax)
Time Frame:Approximately 5 years
Safety Issue:
Description:Part 1 and Part 2
Measure:Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time Frame:Approximately 5 years
Safety Issue:
Description:Part 1 and Part 2
Measure:Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
Time Frame:Approximately 5 years
Safety Issue:
Description:Part 1 and Part 2
Measure:Observed serum concentration at the end of a dosing interval (CTAU)
Time Frame:Approximately 5 years
Safety Issue:
Description:Part 1 and Part 2
Measure:Trough observed serum concentration at the end of the dosing interval (CTROUGH)
Time Frame:Approximately 5 years
Safety Issue:
Description:Part 1 and Part 2
Measure:Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame:Approximately 5 years
Safety Issue:
Description:Part 2, participants with advanced melanoma, using RECIST v1.1 (regardless of baseline serum IL-8 levels)
Measure:Overall Survival (OS)
Time Frame:Approximately 5 years
Safety Issue:
Description:Part 2
Measure:Incidence of AEs
Time Frame:Approximately 5 years
Safety Issue:
Description:Part 2
Measure:Incidence of SAEs
Time Frame:Approximately 5 years
Safety Issue:
Description:Part 2
Measure:Incidence of AEs leading to discontinuation
Time Frame:Approximately 5 years
Safety Issue:
Description:Part 2
Measure:Incidence of death
Time Frame:Approximately 5 years
Safety Issue:
Description:Part 2
Measure:Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame:Approximately 5 years
Safety Issue:
Description:Part 2
Measure:Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time Frame:Approximately 5 years
Safety Issue:
Description:Part 2
Measure:Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time Frame:Approximately 5 years
Safety Issue:
Description:Part 2

Details

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

Last Updated

March 12, 2021