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Trial record 1 of 1 for:    NCT03184870
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A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03184870
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE June 9, 2017
First Posted Date  ICMJE June 14, 2017
Last Update Posted Date August 19, 2020
Actual Study Start Date  ICMJE August 4, 2017
Estimated Primary Completion Date January 10, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
  • Adverse events (AEs) [ Time Frame: Approximately 4 years ]
    Measured by incidence of AEs
  • Serious adverse events (SAEs) [ Time Frame: Approximately 4 years ]
    Measured by incidence of SAEs
  • AEs meeting protocol-defined dose limiting toxicity criteria [ Time Frame: Approximately 6 months ]
    Measured by incidence of AEs that meet the protocol-defined dose limiting toxicity criteria
  • AEs leading to discontinuation [ Time Frame: Approximately 4 years ]
    Measured by incidence of AEs leading to discontinuation
  • Death [ Time Frame: Approximately 4 years ]
    Measured by incidence of deaths
  • Incidence of laboratory abnormalities [ Time Frame: Approximately 4 years ]
    Measured by any laboratory test result that is clinically significant or meets the definition of an SAE, any laboratory test result abnormality that required the patient to have study treatment discontinued or interrupted, or any laboratory test result abnormality that required the participant to receive specific corrective therapy
  • Electrocardiogram (ECG) [ Time Frame: Approximately 4 years ]
    ECGs will be evaluated by the investigator for any clinically significant changes or for changes meeting dose modifying criteria.
  • Summary measures of vital signs [ Time Frame: Approximately 4 years ]
    Including weight, body temperature, respiratory rate, pulse oximetry, seated blood pressure and heart rate.
  • Overall response rate (ORR) [ Time Frame: Approximately 2 years ]
    Part 2 Only: ORR is defined as the proportion of all treated participants whose Best overall response (BOR) is either complete response or partial response. BOR for a participant will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator.
  • Median duration of response (DOR) [ Time Frame: Approximately 2 years ]
    Part 2 Only: DOR for a participant with a BOR of CR or PR, is defined as the time between the date of first response and the date of the first objectively documented tumor progression per RECIST v1.1 or death, whichever occurs first.
  • Progression free survival (PFS) rate [ Time Frame: At 24 weeks ]
    Part 2 Only: PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first.
  • Decrease in regulatory T cells (Treg) & tumor-associated macrophages (TAM) in tumor samples [ Time Frame: Approximately 4 years ]
    Part 1 Only: Examination of tumor-associated immune cells and microenvironment, through proteomics.
Original Primary Outcome Measures  ICMJE
 (submitted: June 9, 2017)
  • Adverse events (AEs) [ Time Frame: Approximately 4 years ]
    Measured by incidence of AEs
  • Serious adverse events (SAEs) [ Time Frame: Approximately 4 years ]
    Measured by incidence of SAEs
  • AEs meeting protocol-defined dose limiting toxicity criteria [ Time Frame: Approximately 6 months ]
    Measured by incidence of AEs that meet the protocol-defined dose limiting toxicity criteria
  • AEs leading to discontinuation [ Time Frame: Approximately 4 years ]
    Measured by incidence of AEs leading to discontinuation
  • Death [ Time Frame: Approximately 4 years ]
    Measured by incidence of deaths
  • Incidence of laboratory abnormalities [ Time Frame: Approximately 4 years ]
    Measured by any laboratory test result that is clinically significant or meets the definition of an SAE, any laboratory test result abnormality that required the patient to have study treatment discontinued or interrupted, or any laboratory test result abnormality that required the participant to receive specific corrective therapy
  • Electrocardiogram (ECG) [ Time Frame: Approximately 4 years ]
    ECGs will be evaluated by the investigator for any clinically significant changes or for changes meeting dose modifying criteria.
  • Summary measures of vital signs [ Time Frame: Approximately 4 years ]
    Including weight, body temperature, respiratory rate, pulse oximetry, seated blood pressure and heart rate.
  • Objective response rate (ORR) [ Time Frame: Approximately 4 years ]
    ORR is defined as the proportion of all treated participants whose Best overall response (BOR) is either complete response or partial response. BOR for a participant will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator
  • Median duration of response (DOR) [ Time Frame: Approximately 4 years ]
    DOR for a participant with a BOR of CR or PR, is defined as the time between the date of first response and the date of the first objectively documented tumor progression per RECIST v1.1 or death, whichever occurs first
  • Progression free survival (PFS) rate [ Time Frame: At 24 weeks ]
    PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2018)
  • Maximum observed plasma concentration (Cmax) [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation
  • Time of maximum observed plasma concentration (Tmax) [ Time Frame: Approximately 4 years ]
    Summary statistics: medians and ranges
  • Trough observed plasma concentration (Ctrough) [ Time Frame: Approximately 4 years ]
    Summary statistics to assess attainment of steady state: geometric means and coefficients of variation; plots vs time by dose
  • Observed plasma concentration at 24 hours post dose (C24) [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation
  • Area under the concentration-time curve from time 0 to 8 hours postdose [AUC(0-8)] [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation
  • Area under the concentration-time curve from time 0 to 24 hours post dose [AUC(0-24)] [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation
  • Apparent total body clearance (CLT/F) [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation
  • Accumulation index, calculated based on ratio of AUC(0-24) and Cmax at steady state to after the first dose (AI) [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation
  • Renal clearance (CLR) [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation
  • Percent urinary recovery over 24 hours corrected for molecular weight (%UR) [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation
  • Ratio of metabolite Cmax to parent Cmax, corrected for molecular (MR_Cmax) [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation
  • Ratio of metabolite AUC(0-24) to parent AUC(0-24), corrected for molecular weight [MR_AUC(0-24)] [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation
  • Frequency of positive anti-drug antibody (ADA) to nivolumab during combination therapy [ Time Frame: Approximately 4 years ]
    Frequency distribution of baseline ADA-positive participants and ADA-positive participants after initiation of the treatment
  • Decrease in regulatory T cells (Treg) & tumor-associated macrophages (TAM) in tumor samples [ Time Frame: Approximately 4 years ]
    Part 2 Only: Examination of tumor-associated immune cells and microenvironment, through proteomics.
  • Overall response rate (ORR) [ Time Frame: Approximately 2 years ]
    Part 1 Only: ORR is defined as the proportion of all treated participants whose Best overall response (BOR) is either complete response or partial response. BOR for a participant will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by investigator.
  • Median duration of response (DOR) [ Time Frame: Approximately 2 years ]
    Part 1 Only: DOR for a participant with a BOR of CR or PR, is defined as the time between the date of first response and the date of the first objectively documented tumor progression per RECIST v1.1 or death, whichever occurs first
  • Progression free survival (PFS) rate [ Time Frame: Approximately 2 years ]
    Part 1 Only: PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2017)
  • Maximum observed plasma concentration (Cmax) [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation
  • Time of maximum observed plasma concentration (Tmax) [ Time Frame: Approximately 4 years ]
    Summary statistics: medians and ranges
  • Trough observed plasma concentration (Ctrough) [ Time Frame: Approximately 4 years ]
    Summary statistics to assess attainment of steady state: geometric means and coefficients of variation; plots vs time by dose
  • Observed plasma concentration at the end of the dosing interval (Ctau) [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation
  • Area under the concentration-time curve from time 0 to 8 hours postdose [AUC(0-8)] [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation
  • Area under the concentration-time curve in one dosing interval [AUC(TAU)] [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation
  • Apparent total body clearance (CLT/F) [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation
  • Accumulation index, calculated based on ratio of AUC(TAU) and Cmax at steady state to after the first dose (AI) [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation
  • Renal clearance (CLR) [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation
  • Percent urinary recovery over 24 hours corrected for molecular weight (%UR) [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation
  • Ratio of metabolite Cmax to parent Cmax, corrected for molecular (MR_Cmax) [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation
  • Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight [MR_AUC(TAU)] [ Time Frame: Approximately 4 years ]
    Summary statistics: geometric means and coefficients of variation
  • Frequency of positive anti-drug antibody (ADA) to nivolumab during combination therapy [ Time Frame: Approximately 4 years ]
    Frequency distribution of baseline ADA-positive participants and ADA-positive participants after initiation of the treatment
  • Decrease in regulatory T cells (Treg) & tumor-associated macrophages (TAM) in tumor samples [ Time Frame: Approximately 4 years ]
    Examination of tumor-associated immune cells and microenvironment, through proteomics
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-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors
Official Title  ICMJE A Phase 1b/2 Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Patients With Advanced Solid Tumors
Brief Summary This study will evaluate the safety profile, tolerability, PK, PD, and preliminary efficacy of BMS-813160 alone or in combination with either chemotherapy or nivolumab in participants with metastatic colorectal and pancreatic cancers.
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
  • Colorectal Cancer
  • Pancreatic Cancer
Intervention  ICMJE
  • Drug: BMS-813160
    specified dose on specified days
  • Biological: Nivolumab
    specified dose on specified days
    Other Names:
    • Opdivo
    • BMS-936558
  • Drug: Nab-paclitaxel
    chemotherapy regimen
  • Drug: Gemcitabine
    chemotherapy regimen
  • Drug: 5-fluorouracil (5-FU)
    chemotherapy regimen
  • Drug: Leucovorin
    chemotherapy regimen
  • Drug: Irinotecan
    chemotherapy regimen
Study Arms  ICMJE
  • Experimental: Combination Therapy 1
    BMS-813160 with 5-fluorouracil (5-FU), leucovorin containing regimens in combination with irinotecan
    Interventions:
    • Drug: BMS-813160
    • Drug: 5-fluorouracil (5-FU)
    • Drug: Leucovorin
    • Drug: Irinotecan
  • Experimental: Combination Therapy 2
    BMS-813160, nab/paclitaxel and gemcitabine
    Interventions:
    • Drug: BMS-813160
    • Drug: Nab-paclitaxel
    • Drug: Gemcitabine
  • Experimental: Combination Therapy 3
    BMS-813160 and Nivolumab
    Interventions:
    • Drug: BMS-813160
    • Biological: Nivolumab
  • Experimental: Combination Therapy 4
    BMS-813160, nab/paclitaxel + gemcitabine, and Nivolumab
    Intervention: Drug: BMS-813160
  • Experimental: Combination Therapy 5
    5-fluorouracil (5-FU), leucovorin containing regimens in combination with irinotecan
    Interventions:
    • Drug: 5-fluorouracil (5-FU)
    • Drug: Leucovorin
    • Drug: Irinotecan
  • Experimental: Combination Therapy 6
    Nab/paclitaxel and gemcitabine
    Interventions:
    • Drug: Nab-paclitaxel
    • Drug: Gemcitabine
  • Experimental: Monotherapy
    BMS-813160
    Intervention: Drug: BMS-813160
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: September 6, 2018)
348
Original Estimated Enrollment  ICMJE
 (submitted: June 9, 2017)
260
Estimated Study Completion Date  ICMJE February 23, 2023
Estimated Primary Completion Date January 10, 2022   (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:

  • Participants must have metastatic colorectal or pancreatic cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
  • Ability to swallow pills or capsules
  • All participants will be required to undergo mandatory pre and on-treatment biopsies
  • Adequate marrow function
  • Adequate other organ functions
  • Ability to comply with study visits, treatment, procedures, PK and PD sample collection, and required study follow-up

Exclusion Criteria:

  • Histology other than adenocarcinoma (neuroendocrine or acinar cell)
  • Suspected, known, or progressive CNS metastases (Imaging required only if participants are symptomatic)
  • Participants with active, known or suspected autoimmune disease
  • Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
  • Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity
  • Prior treatment with CCR2 and/or CCR5 inhibitors, PD-1, PD(L)-1 or CTLA-4 antibodies
  • History of allergy to study treatments or any of its components of the study arm that participant is enrolling

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,   Belgium,   Canada,   France,   Germany,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03184870
Other Study ID Numbers  ICMJE CV202-103
2017-001725-40 ( 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 August 2020

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