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

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ClinicalTrials.gov Identifier: NCT03400332
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE January 12, 2018
First Posted Date  ICMJE January 17, 2018
Last Update Posted Date April 19, 2021
Actual Study Start Date  ICMJE February 12, 2018
Estimated Primary Completion Date February 28, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2021)
  • Incidence of adverse events (AE) [ Time Frame: Approximately 5 years ]
    Part 1
  • Incidence of serious adverse events (SAE) [ Time Frame: Approximately 5 years ]
    Part 1
  • Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria [ Time Frame: Approximately 5 years ]
    Part 1
  • Incidence of AEs leading to discontinuation [ Time Frame: Approximately 5 years ]
    Part 1
  • Incidence of deaths [ Time Frame: Approximately 5 years ]
    Part 1
  • Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Approximately 5 years ]
    Part 1
  • Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Approximately 5 years ]
    Part 1
  • Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Approximately 5 years ]
    Part 1
  • 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 ]
    Part 2, participants with advanced melanoma, selected by baseline serum interleukin-8 (IL-8) level using RECIST v1.1
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2018)
  • Incidence of adverse events (AE) [ Time Frame: Approximately 5 years ]
  • Incidence of serious adverse events (SAE) [ Time Frame: Approximately 5 years ]
  • Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria [ Time Frame: Approximately 5 years ]
  • Incidence of AEs leading to discontinuation [ Time Frame: Approximately 5 years ]
  • Incidence of deaths [ Time Frame: Approximately 5 years ]
  • Incidence of labornatory abnormalities [ Time Frame: Approximately 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2021)
  • 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 ]
    Part 1 and Part 2
  • Median duration of response (mDOR) per response evaluation criteria in solid tumors (RECIST) v1.1 [ Time Frame: Approximately 5 years ]
    Part 1
  • Incidence of anti-drug antibody (ADA) to BMS-986253 [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2
  • Serum biomarker concentration [ Time Frame: Approximately 5 years ]
    Part 1
  • Maximum observed serum concentration (Cmax) [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2
  • Time of maximum observed serum concentration (Tmax) [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2
  • Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2
  • Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2
  • Observed serum concentration at the end of a dosing interval (CTAU) [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2
  • Trough observed serum concentration at the end of the dosing interval (CTROUGH) [ Time Frame: Approximately 5 years ]
    Part 1 and Part 2
  • 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 ]
    Part 2, participants with advanced melanoma, using RECIST v1.1 (regardless of baseline serum IL-8 levels)
  • Overall Survival (OS) [ Time Frame: Approximately 5 years ]
    Part 2
  • Incidence of AEs [ Time Frame: Approximately 5 years ]
    Part 2
  • Incidence of SAEs [ Time Frame: Approximately 5 years ]
    Part 2
  • Incidence of AEs leading to discontinuation [ Time Frame: Approximately 5 years ]
    Part 2
  • Incidence of death [ Time Frame: Approximately 5 years ]
    Part 2
  • Incidence of clinically significant changes in clinical laboratory results: Hematology tests [ Time Frame: Approximately 5 years ]
    Part 2
  • Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [ Time Frame: Approximately 5 years ]
    Part 2
  • Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [ Time Frame: Approximately 5 years ]
    Part 2
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2018)
  • Overall response rate (ORR) [ Time Frame: Approximately 5 years ]
  • Median duration of response (mDOR) [ Time Frame: Approximately 5 years ]
  • Incidence of anti-drug antibody (ADA) to BMS-986253 [ Time Frame: Approximately 5 years ]
  • Serum biomarker concentration [ Time Frame: Approximately 5 years ]
  • Maximum observed serum concentration (Cmax) [ Time Frame: Approximately 5 years ]
  • Time of maximum observed serum concentration (Tmax) [ Time Frame: Approximately 5 years ]
  • Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Approximately 5 years ]
  • Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Approximately 5 years ]
  • Observed serum concentration at the end of a dosing interval (CTAU) [ Time Frame: Approximately 5 years ]
  • Trough observed serum concentration at the end of the dosing interval (CTROUGH) [ Time Frame: Approximately 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
Official Title  ICMJE A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cancer
Intervention  ICMJE
  • Drug: BMS-986253
    Specified dose on specified days
  • Biological: Nivolumab
    Specified dose on specified days
    Other Names:
    • BMS-936558
    • Opdivo
  • Biological: Ipilimumab
    Specified dose on specified days
    Other Names:
    • BMS-734016
    • YERVOY
  • Other: Placebo
    Specified dose on specified days
Study Arms  ICMJE
  • Experimental: Part 1A: BMS-986253 + nivolumab
    Interventions:
    • Drug: BMS-986253
    • Biological: Nivolumab
  • Experimental: Part 1B: BMS-986253 + nivolumab
    Interventions:
    • Drug: BMS-986253
    • Biological: Nivolumab
  • Experimental: Part 1C: BMS-986253 + nivolumab + ipilimumab
    Interventions:
    • Drug: BMS-986253
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Experimental: Part 2A: BMS-986253 + nivolumab + ipilimumab
    Interventions:
    • Drug: BMS-986253
    • Biological: Nivolumab
    • Biological: Ipilimumab
  • Placebo Comparator: Part 2B: Placebo + nivolumab + ipilimumab
    Interventions:
    • Biological: Nivolumab
    • Biological: Ipilimumab
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 10, 2021)
372
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2018)
260
Estimated Study Completion Date  ICMJE June 8, 2024
Estimated Primary Completion Date February 28, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
Listed Location Countries  ICMJE Belgium,   Canada,   Germany,   Italy,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03400332
Other Study ID Numbers  ICMJE CA027-002
2018-000340-26 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP