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Study of Urelumab in Subjects With Advanced and/or Metastatic Malignant Tumors

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: NCT02534506
Recruitment Status : Completed
First Posted : August 27, 2015
Last Update Posted : May 18, 2020
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE August 5, 2015
First Posted Date  ICMJE August 27, 2015
Last Update Posted Date May 18, 2020
Actual Study Start Date  ICMJE November 6, 2015
Actual Primary Completion Date November 11, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2015)
  • Safety of urelumab monotherapy as measured by the dose limiting toxicity (DLT) in subjects with advanced and/or metastatic malignant tumors [ Time Frame: From day 1 of treatment up to 60 days of follow-up ]
  • Safety of urelumab monotherapy as measured by adverse events (AEs) and serious adverse events (SAEs) in subjects with advanced and/or metastatic malignant tumors [ Time Frame: From day 1 of treatment up to 60 days of follow-up ]
  • Tolerability of urelumab monotherapy as measured by the DLT in subjects with advanced and/or metastatic malignant tumors [ Time Frame: From day 1 of treatment up to 60 days of follow-up ]
  • Tolerability of urelumab monotherapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors [ Time Frame: From day 1 of treatment up to 60 days of follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2015)
  • Safety of urelumab-nivolumab combination therapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors [ Time Frame: From day 1 of treatment up to 100 days of follow-up ]
  • Tolerability of urelumab-nivolumab combination therapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors [ Time Frame: From day 1 of treatment up to 100 days of follow-up ]
  • Cmax (Maximum observed serum concentration) of urelumab when administered alone [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • Ctrough (Trough observed serum concentration) of urelumab when administered alone [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • Tmax (Time of maximum observed serum concentration) of urelumab when administered alone [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • AUC(0-T) [Area under the concentration-time curve from time zero to the last quantifiable concentration] of urelumab when administered alone [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • AUC(TAU) [Area under the concentration-time curve in one dosing interval] of urelumab when administered alone [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • AUC(INF) [Area under the concentration-time curve from time zero to infinity and the extrapolated area] of urelumab when administered alone [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • T-HALF (Elimination half life) of urelumab when administered alone [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • CLT (Total body clearance) of urelumab when administered alone [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • Vss (Volume of distribution at steady state) of urelumab when administered alone [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • AI (Accumulation Index: ratio of AUC(TAU) and Cmax in cycle at steady state to those after the first cycle) of urelumab when administered alone [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • Cmax of urelumab when co-administered [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up ]
    28 days/cycle for combination therapy of Urelumab and Nivolumab
  • Coeff of urelumab when co-administered [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up ]
    28 days/cycle for combination therapy of Urelumab and Nivolumab
  • Ctrough of urelumab and nivolumab when co-administered [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up ]
    28 days/cycle for combination therapy of Urelumab and Nivolumab
  • Tmax of urelumab and nivolumab when co-administered [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up ]
    28 days/cycle for combination therapy of Urelumab and Nivolumab
  • AUC(0-T) of urelumab and nivolumab when co-administered [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up ]
    28 days/cycle for combination therapy of Urelumab and Nivolumab
  • AUC(TAU) of urelumab and nivolumab when co-administered [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up ]
    28 days/cycle for combination therapy of Urelumab and Nivolumab
  • AUC(INF) of urelumab and nivolumab when co-administered [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up ]
    28 days/cycle for combination therapy of Urelumab and Nivolumab
  • T-HALF of urelumab when co-administered [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up ]
    28 days/cycle for combination therapy of Urelumab and Nivolumab
  • CLT of urelumab when co-administered [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up ]
    28 days/cycle for combination therapy of Urelumab and Nivolumab
  • Vss of urelumab when co-administered [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up ]
    28 days/cycle for combination therapy of Urelumab and Nivolumab
  • Anti-drug Antibody (ADA) status of the subject in response to Urelumab when administered alone [ Time Frame: Cycle 1, 2, 4, 8, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • ADA status of the subject in response to Urelumab and Nivolumab when co-administered [ Time Frame: Cycle 1, 2, 4, 5, 9, up to 100 days of follow up ]
    28 days/cycle for combination therapy of Urelumab and Nivolumab
  • Best overall response (BOR) of urelumab monotherapy [ Time Frame: Every 6-8 weeks during the treatment period ]
  • BOR of urelumab and nivolumab combination therapy [ Time Frame: Every 6-8 weeks during the treatment period ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2015)
  • Safety of urelumab-nivolumab combination therapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors [ Time Frame: From day 1 of treatment up to 100 days of follow-up ]
  • Tolerability of urelumab-nivolumab combination therapy as measured by AEs and SAEs in subjects with advanced and/or metastatic malignant tumors [ Time Frame: From day 1 of treatment up to 100 days of follow-up ]
  • Cmax (Maximum observed serum concentration) of urelumab when administered alone [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • Ctrough (Trough observed serum concentration) of urelumab when administered alone [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • Tmax (Time of maximum observed serum concentration) of urelumab when administered alone [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • AUC(0-T) [Area under the concentration-time curve from time zero to the last quantifiable concentration] of urelumab when administered alone [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • AUC(TAU) [Area under the concentration-time curve in one dosing interval] of urelumab when administered alone [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • AUC(INF) [Area under the concentration-time curve from time zero to infinity and the extrapolated area] of urelumab when administered alone [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • T-HALF (Elimination half life) of urelumab when administered alone [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • CLT (Total body clearance) of urelumab when administered alone [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • Vss (Volume of distribution at steady state) of urelumab when administered alone [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • AI (Accumulation Index: ratio of AUC(TAU) and Cmax in cycle at steady state to those after the first cycle) of urelumab when administered alone [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 7, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • Cmax of urelumab and nivolumab when co-administered [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up ]
    28 days/cycle for combination therapy of Urelumab and Nivolumab
  • Ctrough of urelumab and nivolumab when co-administered [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up ]
    28 days/cycle for combination therapy of Urelumab and Nivolumab
  • Tmax of urelumab and nivolumab when co-administered [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up ]
    28 days/cycle for combination therapy of Urelumab and Nivolumab
  • AUC(0-T) of urelumab and nivolumab when co-administered [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up ]
    28 days/cycle for combination therapy of Urelumab and Nivolumab
  • AUC(TAU) of urelumab and nivolumab when co-administered [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up ]
    28 days/cycle for combination therapy of Urelumab and Nivolumab
  • AUC(INF) of urelumab and nivolumab when co-administered [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up ]
    28 days/cycle for combination therapy of Urelumab and Nivolumab
  • T-HALF of urelumab and nivolumab when co-administered [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up ]
    28 days/cycle for combination therapy of Urelumab and Nivolumab
  • CLT of urelumab and nivolumab when co-administered [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up ]
    28 days/cycle for combination therapy of Urelumab and Nivolumab
  • Vss of urelumab and nivolumab when co-administered [ Time Frame: Cycle 1, 2, 3, 4, 5, 6, 9, up to 100 days of follow up ]
    28 days/cycle for combination therapy of Urelumab and Nivolumab
  • Anti-drug Antibody (ADA) status of the subject in response to Urelumab when administered alone [ Time Frame: Cycle 1, 2, 4, 8, 12, 16, up to 60 days of follow up ]
    21 days/cycle for Urelumab monotherapy
  • ADA status of the subject in response to Urelumab and Nivolumab when co-administered [ Time Frame: Cycle 1, 2, 4, 5, 9, up to 100 days of follow up ]
    28 days/cycle for combination therapy of Urelumab and Nivolumab
  • Best overall response (BOR) of urelumab monotherapy [ Time Frame: Every 6-8 weeks during the treatment period ]
  • BOR of urelumab and nivolumab combination therapy [ Time Frame: Every 6-8 weeks during the treatment period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Urelumab in Subjects With Advanced and/or Metastatic Malignant Tumors
Official Title  ICMJE A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics and Immunoregulatory Activity of Urelumab (BMS-663513) in Subjects With Advanced and/or Metastatic Malignant Tumors
Brief Summary The purpose of this study is to assess the safety and tolerability of BMS-663513 in subjects with advanced and/or metastatic malignant tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignant Tumors
Intervention  ICMJE
  • Drug: Urelumab
  • Drug: Nivolumab
Study Arms  ICMJE Experimental: Urelumab (+ Nivolumab) intravenous (IV) infusion
Interventions:
  • Drug: Urelumab
  • Drug: Nivolumab
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 Completed
Estimated Enrollment  ICMJE
 (submitted: August 25, 2015)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 11, 2016
Actual Primary Completion Date November 11, 2016   (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:

  • Subjects with previously treated advanced malignant solid tumor
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • For certain subjects, willing and able to provide pre-treatment tumor sample

Exclusion Criteria:

  • Known or suspected 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02534506
Other Study ID Numbers  ICMJE CA186-110
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
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date May 2020

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