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Completed

NCT Number: NCT03203876

A Safety Study of Lirilumab in Combination With Nivolumab or in Combination With Nivolumab and Ipilimumab in Advanced and/or Metastatic Solid Tumors

The purpose of this study is to determine whether lirilumab in combination with nivolumab or in combination with nivolumab and ipilimumab is safe in the treatment of advanced and/or metastatic solid tumors

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Key information

Conditions

Advanced Cancer

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Kashiwa-shi, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

  • Participants must have histologic or cytologic confirmation of a solid malignancy that is advanced (metastatic and/or unresectable)
  • Presence of at least 1 lesion with measurable disease as defined by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) criteria for response assessment
  • The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria

  • Participants with untreated central nervous system (CNS) metastases
  • Participants with an active, known, or suspected autoimmune disease
  • Uncontrolled or significant cardiovascular disease

Other protocol defined inclusion/exclusion criteria could apply

Treatment and study plan

Lirilumab

Biological

Specified dose on specified days

Other names: BMS-986015

Nivolumab

Biological

Specified dose on specified days

Other names: BMS-936558, Opdivo

Ipilimumab

Biological

Specified dose on specified days

Other names: BMS-734016, Yervoy

Primary outcomes

  1. Incidence of dose-limiting toxicity (DLT)

    Time frame: Up to two years

    To assess the safety and tolerability of lirilumab in combination with nivolumab

  2. Incidence of adverse events (AEs)

    Time frame: Up to two years

    To assess the safety and tolerability of lirilumab in combination with nivolumab

  3. Incidence of serious adverse events (SAEs)

    Time frame: Up to two years

    To assess the safety and tolerability of lirilumab in combination with nivolumab

  4. Incidence of death

    Time frame: Up to two years

    To assess the safety and tolerability of lirilumab in combination with nivolumab

  5. Frequency of laboratory test toxicity grade shifting from baseline

    Time frame: Up to two years

    To assess the safety and tolerability of lirilumab in combination with nivolumab

  6. Incidence of AEs leading to discontinuation

    Time frame: Up to two years

    To assess the safety and tolerability of lirilumab in combination with nivolumab

Secondary outcomes

  1. Incidence of dose-limiting toxicity (DLT)

    Time frame: Up to two years

    To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab

  2. Incidence of adverse events (AEs)

    Time frame: Up to two years

    To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab

  3. Incidence of serious adverse events (SAEs)

    Time frame: Up to two years

    To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab

  4. Incidence of death

    Time frame: Up to two years

    To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab

  5. Frequency of laboratory test toxicity grade shifting from baseline

    Time frame: Up to two years

    To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab

  6. Maximum serum observed concentration (Cmax)

    Time frame: Up to two years

    To characterize the Pharmacokinetic (PK) of lirilumab given in combination with nivolumab

  7. Time of maximum observed serum concentration (Tmax)

    Time frame: Up to two years

    To characterize the PK of lirilumab given in combination with nivolumab

  8. Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration [AUC(0-T)]

    Time frame: Up to two years

    To characterize the PK of lirilumab given in combination with nivolumab

  9. Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

    Time frame: Up to two years

    To characterize the PK of lirilumab given in combination with nivolumab

  10. Trough observed serum concentration (Ctrough)

    Time frame: Up to two years

    To characterize the PK of lirilumab given in combination with nivolumab

  11. Area under the serum concentration-time curve in one dosing interval [AUC(TAU)]

    Time frame: Up to two years

    To characterize the PK of lirilumab given in combination with nivolumab

  12. Clearance (CL)

    Time frame: Up to two years

    To characterize the PK and immunogenicity of lirilumab given in combination with nivolumab

  13. Volume of distribution at steady state (Vss)

    Time frame: Up to two years

    To characterize the PK of lirilumab given in combination with nivolumab

  14. Ratio of an exposure measure at steady-state to that after the first dose (AI)

    Time frame: Up to two years

    To characterize the PK of lirilumab given in combination with nivolumab

  15. Half-life (T-HALF)

    Time frame: Up to two years

    To characterize the PK of lirilumab given in combination with nivolumab

  16. Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALF eff)

    Time frame: Up to two years

    To characterize the PK of lirilumab given in combination with nivolumab

  17. Best overall response (BOR)

    Time frame: Up to two years

    To assess the preliminary anti-tumor activity

  18. Duration of response (DOR)

    Time frame: Up to two years

    To assess the preliminary anti-tumor activity

  19. Incidence of anti-drug antibody (ADA)

    Time frame: Up to two years

    To characterize immunogenicity

  20. Incidence of AEs leading to discontinuation

    Time frame: Up to two years

    To assess the safety and tolerability of lirilumab in combination with nivolumab and ipilimumab

  21. Maximum serum observed concentration (Cmax)

    Time frame: Up to two years

    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

  22. Time of maximum observed serum concentration (Tmax)

    Time frame: Up to two years

    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

  23. Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration [AUC(0-T)]

    Time frame: Up to two years

    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

  24. Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]

    Time frame: Up to two years

    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

  25. Trough observed serum concentration (Ctrough)

    Time frame: Up to two years

    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

  26. Area under the serum concentration-time curve in one dosing interval [AUC(TAU)]

    Time frame: Up to two years

    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

  27. Clearance (CL)

    Time frame: Up to two years

    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

  28. Volume of distribution at steady state (Vss)

    Time frame: Up to two years

    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

  29. Ratio of an exposure measure at steady-state to that after the first dose (AI)

    Time frame: Up to two years

    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

  30. Half-life (T-HALF)

    Time frame: Up to two years

    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

  31. Effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (T-HALF eff)

    Time frame: Up to two years

    To characterize the PK of lirilumab given in combination with nivolumab and ipilimumab

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 and Pharmacokinetics of Anti-KIR Monoclonal Antibody (Lirilumab, BMS-986015) in Combination With Anti-PD-1 Monoclonal Antibody (Nivolumab,BMS-936558) or in Combination With Nivolumab and Anti-CTLA-4 Monoclonal Antibody (Ipilimumab, BMS-734016) in Advanced and/or Metastatic Solid Tumors

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 29, 2017
Registry last updated
Mar 10, 2022

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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