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OpenTrials
Completed

NCT Number: NCT02534506

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

The purpose of this study is to assess the safety and tolerability of BMS-663513 in subjects with advanced and/or metastatic malignant tumors.

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Key information

Conditions

Malignant Tumors Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Kobe, Hyōgo, 6500017, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urelumab

Drug

Nivolumab

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 27, 2015
Registry last updated
May 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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