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An Investigational Immuno-therapy Study of Experimental Medication BMS-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02598960
Recruitment Status : Completed
First Posted : November 6, 2015
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE October 21, 2015
First Posted Date  ICMJE November 6, 2015
Last Update Posted Date December 21, 2020
Actual Study Start Date  ICMJE October 9, 2015
Actual Primary Completion Date December 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2019)
  • Incidence of Adverse Events [ Time Frame: Up to 30 days after the last dose of study drug ]
  • Incidence of Serious Adverse Events [ Time Frame: Up to 30 days after the last dose of study drug ]
  • Incidence of Adverse Events leading to discontinuation [ Time Frame: Up to 30 days after the last dose of study drug ]
  • Incidence of Death [ Time Frame: Up to 30 days after the last dose of study drug ]
  • Incidence of Clinical Laboratory Abnormalities [ Time Frame: Up to 30 days after the last dose of study drug ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2015)
Safety of BMS-986156 based on number of incidence of adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation and deaths in addition to clinical laboratory test abnormalities [ Time Frame: Up to 30 days after the last dose of study drug ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2019)
  • Objective response rate (ORR) [ Time Frame: Approximately 3 years ]
  • Progression free survival rate (PFSR) [ Time Frame: At week 24 ]
  • Duration of response [ Time Frame: Approximately 3 years ]
  • Maximum observed concentration (Cmax) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
  • Time of maximum observed concentration (Tmax) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
  • Area under the concentration-time curve in one dosing interval (AUC [TAU]) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
  • Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
  • Anti-drug antibody (ADA) response to BMS-986156 [ Time Frame: Day 1 to 56 days ]
  • Anti-drug antibody response to BMS-986156 and Nivolumab [ Time Frame: Day 1 to 56 days ]
  • Best Overall Response(ORR) [ Time Frame: Approximately 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2015)
  • Objective response rate (ORR) [ Time Frame: Approximately 3 years ]
    ORR is defined as the proportion of all treated subjects whose best overall response is either a complete response (CR) or partial response (PR)
  • Progression free survival rate (PFSR) [ Time Frame: Approximately 3 years ]
  • Duration of response [ Time Frame: Approximately 3 years ]
    Duration of response is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first
  • Maximum observed concentration (Cmax) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
  • Time of maximum observed concentration (Tmax) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
  • Area under the concentration-time curve in one dosing interval (AUC [TAU]) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
  • Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T) of BMS-986156 [ Time Frame: Day 1 to 56 days ]
  • Anti-drug antibody (ADA) response to BMS-986156 [ Time Frame: Day 1 to 56 days ]
  • Anti-drug antibody response to BMS-986156 and Nivolumab [ Time Frame: Day 1 to 56 days ]
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-986156, Given by Itself or in Combination With Nivolumab in Patients With Solid Cancers or Cancers That Have Spread.
Official Title  ICMJE A Phase 1/2a Dose Escalation and Cohort Expansion Study for Safety, Tolerability, and Efficacy of BMS-986156 Administered Alone and in Combination With Nivolumab (BMS-936558, Anti PD-1 Monoclonal Antibody) in Advanced Solid Tumors
Brief Summary The purpose of this study is to evaluate the safety and tumor-shrinking ability of experimental medication BMS-986156, when given by itself or in combination with nivolumab in patients with solid cancers that are advanced or cancers that 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 Solid Tumors
Intervention  ICMJE
  • Drug: BMS-986156
  • Drug: Nivolumab
Study Arms  ICMJE
  • Experimental: BMS-986156: Dose Escalation
    Intervention: Drug: BMS-986156
  • Experimental: BMS-986156 + nivolumab (nivo): Dose Escalation
    Interventions:
    • Drug: BMS-986156
    • Drug: Nivolumab
  • Experimental: BMS-986156: Dose Expansion
    Intervention: Drug: BMS-986156
  • Experimental: BMS-986156 + nivolumab (nivo): Dose Expansion
    Interventions:
    • Drug: BMS-986156
    • Drug: Nivolumab
  • Experimental: BMS986156 + Nivo: Cohort Expansion
    Interventions:
    • Drug: BMS-986156
    • Drug: Nivolumab
Publications * Heinhuis KM, Carlino M, Joerger M, Di Nicola M, Meniawy T, Rottey S, Moreno V, Gazzah A, Delord JP, Paz-Ares L, Britschgi C, Schilder RJ, O'Byrne K, Curigliano G, Romano E, Patah P, Wang R, Liu Y, Bajaj G, Siu LL. Safety, Tolerability, and Potential Clinical Activity of a Glucocorticoid-Induced TNF Receptor-Related Protein Agonist Alone or in Combination With Nivolumab for Patients With Advanced Solid Tumors: A Phase 1/2a Dose-Escalation and Cohort-Expansion Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):100-107. doi: 10.1001/jamaoncol.2019.3848.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2019)
331
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2015)
260
Actual Study Completion Date  ICMJE December 16, 2020
Actual Primary Completion Date December 16, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • For Dose Escalation:

    • Subjects with any previously treated advanced (metastatic or refractory) solid tumor
  • For Cohort Expansion:

    • Subjects must have a previously treated advanced solid tumor to be eligible
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Willing and able to provide pre-treatment and on-treatment fresh tumor biopsy
  • Women of child-bearing potential and men must use an acceptable method of contraception during treatment and for 23 weeks after treatment for women and 31 weeks for men

Exclusion Criteria:

  • Known central nervous system metastases or central nervous system as the only source of disease
  • Other concomitant malignancies (with some exceptions per protocol)
  • Active, known or suspected autoimmune disease
  • Uncontrolled or significant cardiovascular disease
  • History of active or chronic hepatitis (e.g. Hep B or C)
  • Impaired liver or bone marrow function
  • Major surgery less than 1 month before start of the study
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   Germany,   Italy,   Netherlands,   Spain,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02598960
Other Study ID Numbers  ICMJE CA009-002
2015-002505-11 ( 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
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date December 2020

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