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

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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

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.

Condition or disease Intervention/treatment Phase
Malignant Tumors Drug: Urelumab Drug: Nivolumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 6, 2015
Actual Primary Completion Date : November 11, 2016
Actual Study Completion Date : November 11, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Urelumab (+ Nivolumab) intravenous (IV) infusion Drug: Urelumab
Drug: Nivolumab



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. Best overall response (BOR) of urelumab monotherapy [ Time Frame: Every 6-8 weeks during the treatment period ]
  26. BOR of urelumab and nivolumab combination therapy [ Time Frame: Every 6-8 weeks during the treatment period ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02534506


Locations
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Japan
Local Institution
Kobe-shi, Hyogo, Japan, 6500017
Sponsors and Collaborators
Bristol-Myers Squibb
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02534506    
Other Study ID Numbers: CA186-110
First Posted: August 27, 2015    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020

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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
Keywords provided by Bristol-Myers Squibb:
Advanced malignant tumors
Metastatic malignant tumors
Additional relevant MeSH terms:
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Neoplasms
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents