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An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02754141
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE April 22, 2016
First Posted Date  ICMJE April 28, 2016
Last Update Posted Date July 14, 2020
Actual Study Start Date  ICMJE June 20, 2016
Estimated Primary Completion Date November 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2016)
Number of adverse events (AE), serious adverse events (SAE), AEs leading to discontinuation, and deaths [ Time Frame: Up to 100 days after the last dose of study drug ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2019)
  • The effect of BMS-986179 on CD73 enzymatic activity in pre- and on-treatment biopsies [ Time Frame: Approximately 63 days ]
  • The effect of BMS-986179 on CD73 protein expression in pre- and on-treatment biopsies [ Time Frame: Approximately 63 days ]
  • Objective response rate (ORR) [ Time Frame: Approximately 2 years ]
  • Duration of response (DOR) [ Time Frame: Approximately 2 years ]
  • Progression free survival rate (PFSR) [ Time Frame: Approximately 2 years ]
  • Maximum observed serum concentration (Cmax) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Time of maximum observed serum concentration (Tmax) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Area under the serum concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)] [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Apparent terminal half-life (T-HALF) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Effective elimination half-life (T-HALFeff) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Concentration at the end of the dosing interval (Ctau) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Trough observed serum concentration at the end of the dosing interval (Ctrough) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Total body clearance (CLT) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Volume of distribution at steady state (Vss) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Accumulation index (AI) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Apparent volume of distribution of terminal phase (Vz) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Degree of fluctuation or fluctuation index (DF) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Frequency of positive anti-drug antibody (ADA) to BMS-986179 [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Frequency of positive anti-drug antibody (ADA) to nivolumab [ Time Frame: Up to 100 days after the last dose of study drug ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2016)
  • BMS-986179 enzyme assays in pre- and on-treatment biopsies [ Time Frame: Approximately 63 days ]
  • BMS-986179 immunohistochemistry (IHC) in pre- and on-treatment biopsies [ Time Frame: Approximately 63 days ]
  • Objective response rate (ORR) [ Time Frame: Approximately 2 years ]
  • Duration of response (DOR) [ Time Frame: Approximately 2 years ]
  • Progression free survival rate (PFSR) [ Time Frame: Approximately 2 years ]
  • Maximum observed serum concentration (Cmax) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Time of maximum observed serum concentration (Tmax) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Area under the serum concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)] [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)] [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Apparent terminal half-life (T-HALF) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Effective elimination half-life (T-HALFeff) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Concentration at the end of the dosing interval (Ctau) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Trough observed serum concentration at the end of the dosing interval (Ctrough) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Total body clearance (CLT) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Volume of distribution at steady state (Vss) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Accumulation index (AI) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Apparent volume of distribution of terminal phase (Vz) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Degree of fluctuation or fluctuation index (DF) [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Frequency of positive anti-drug antibody (ADA) to BMS-986179 [ Time Frame: Up to 100 days after the last dose of study drug ]
  • Frequency of positive anti-drug antibody (ADA) to nivolumab [ Time Frame: Up to 100 days after the last dose of study drug ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab
Official Title  ICMJE A Phase 1/2a Study of BMS-986179 Administered Alone and in Combination With Nivolumab (BMS-936558) in Subjects With Advanced Solid Tumors
Brief Summary The purpose of this study is to assess the safety and tumor-shrinking ability of experimental medication BMS-986179 alone and when combined with Nivolumab, in patients with solid cancers that are advanced or have spread.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignant Solid Tumor
Intervention  ICMJE
  • Biological: BMS-986179
    Specified dose on specified days
  • Biological: Nivolumab
    Specified dose on specified days
    Other Names:
    • BMS-936558
    • Opdivo
  • Biological: rHuPH20
    Specified dose on specified days
Study Arms  ICMJE
  • Experimental: Arm A-Monotherapy
    BMS-986179, dose as specified
    Intervention: Biological: BMS-986179
  • Experimental: Arm B- Combination Therapy
    BMS-986179 + nivolumab, dose as specified
    Interventions:
    • Biological: BMS-986179
    • Biological: Nivolumab
  • Experimental: Arm C-Combination Therapy
    BMS-986179 + rHuPH20, dose as specified
    Interventions:
    • Biological: BMS-986179
    • Biological: rHuPH20
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: July 25, 2019)
268
Original Estimated Enrollment  ICMJE
 (submitted: April 25, 2016)
204
Estimated Study Completion Date  ICMJE September 19, 2022
Estimated Primary Completion Date November 15, 2020   (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:

  • Solid cancers that are advanced or have spread (for which alternative therapies were deemed not effective)
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Acceptable lab testing results
  • Allow biopsies

Exclusion Criteria:

  • Central nervous system (CNS) tumors
  • Uncontrolled or significant cardiovascular diseases
  • Active or known autoimmune disease
  • Organ transplant

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 Australia,   Canada,   France,   Germany,   Italy,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02754141
Other Study ID Numbers  ICMJE CA013-004
2016-000603-91 ( EudraCT Number )
Has Data Monitoring Committee No
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 July 2020

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